Trial Outcomes & Findings for Look AHEAD: Action for Health in Diabetes (NCT NCT00017953)

Last Updated: 2023-08-02

Results Overview

Number of participants with first on-study occurrence of one of the following major cardiovascular events: fatal and non-fatal myocardial infarctions and strokes, hospitalizations for angina, and cardiovascular deaths

Recruitment status

COMPLETED

Study phase

Target enrollment

5145 participants

Primary outcome timeframe

up to 11 years

Results posted on

2023-08-02

Participant Flow

Participant milestones

Participant milestones
Measure	Lifestyle Intervention Participants in the lifestyle intervention arm are offered individual and group sessions designed to help achieve and maintain weight loss. Lifestyle Intervention: The lifestyle intervention is implemented with individual supervision and group sessions and is aimed at achieving and maintaining at least a 7% decrease in weight from baseline and 175 minutes per week in physical activity. It is implemented during a four-year period with the most intensive application during the first year, less frequent attention during the next three years, and a minimum of twice yearly contacts during an extended follow-up period. To help participants achieve and maintain weight loss, a variety of diet strategies (e.g. prepared meals and liquid formula), exercise strategies, and optional weight loss medications are utilized based on a preset algorithm and participant progress.	Diabetes Support and Education The diabetes support and education arm provides group sessions on diabetes management and social support. Diabetes Support and Education: Participants assigned to diabetes support and education are offered three sessions each year in diabetes management and social support.
Overall Study STARTED	2570	2575
Overall Study COMPLETED	2481	2476
Overall Study NOT COMPLETED	89	99

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Look AHEAD: Action for Health in Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lifestyle Intervention n=2570 Participants Participants in the lifestyle intervention arm are offered individual and group sessions designed to help achieve and maintain weight loss. Lifestyle Intervention: The lifestyle intervention is implemented with individual supervision and group sessions and is aimed at achieving and maintaining at least a 7% decrease in weight from baseline and 175 minutes per week in physical activity. It is implemented during a four-year period with the most intensive application during the first year, less frequent attention during the next three years, and a minimum of twice yearly contacts during an extended follow-up period. To help participants achieve and maintain weight loss, a variety of diet strategies (e.g. prepared meals and liquid formula), exercise strategies, and optional weight loss medications are utilized based on a preset algorithm and participant progress.	Diabetes Support and Education n=2575 Participants The diabetes support and education arm provides group sessions on diabetes management and social support. Diabetes Support and Education: Participants assigned to diabetes support and education are offered three sessions each year in diabetes management and social support.	Total n=5145 Participants Total of all reporting groups
Age, Continuous	58.55 years STANDARD_DEVIATION 6.77 • n=5 Participants	58.85 years STANDARD_DEVIATION 6.86 • n=7 Participants	58.70 years STANDARD_DEVIATION 6.81 • n=5 Participants
Sex: Female, Male Female	1524 Participants n=5 Participants	1534 Participants n=7 Participants	3058 Participants n=5 Participants
Sex: Female, Male Male	1046 Participants n=5 Participants	1041 Participants n=7 Participants	2087 Participants n=5 Participants
Race/Ethnicity, Customized Race / ethnicity · African American / Black	398 Participants n=5 Participants	405 Participants n=7 Participants	803 Participants n=5 Participants
Race/Ethnicity, Customized Race / ethnicity · American Indian / Alaskan Native	131 Participants n=5 Participants	129 Participants n=7 Participants	260 Participants n=5 Participants
Race/Ethnicity, Customized Race / ethnicity · Asian / Pacific Islander	29 Participants n=5 Participants	21 Participants n=7 Participants	50 Participants n=5 Participants
Race/Ethnicity, Customized Race / ethnicity · White	1618 Participants n=5 Participants	1628 Participants n=7 Participants	3246 Participants n=5 Participants
Race/Ethnicity, Customized Race / ethnicity · Hispanic	338 Participants n=5 Participants	337 Participants n=7 Participants	675 Participants n=5 Participants
Race/Ethnicity, Customized Race / ethnicity · Other/Mixed/Unknown	56 Participants n=5 Participants	55 Participants n=7 Participants	111 Participants n=5 Participants
Region of Enrollment United States	2570 participants n=5 Participants	2575 participants n=7 Participants	5145 participants n=5 Participants
Weight	100.54 kg STANDARD_DEVIATION 19.65 • n=5 Participants	100.86 kg STANDARD_DEVIATION 18.83 • n=7 Participants	100.7 kg STANDARD_DEVIATION 19.24 • n=5 Participants
Height	167.22 cm STANDARD_DEVIATION 9.59 • n=5 Participants	167.27 cm STANDARD_DEVIATION 9.86 • n=7 Participants	167.25 cm STANDARD_DEVIATION 9.72 • n=5 Participants
Body mass index	35.89 kg/m^2 STANDARD_DEVIATION 6.01 • n=5 Participants	36.00 kg/m^2 STANDARD_DEVIATION 5.76 • n=7 Participants	35.95 kg/m^2 STANDARD_DEVIATION 5.88 • n=5 Participants
Waist Circumference	113.80 cm STANDARD_DEVIATION 14.35 • n=5 Participants	114.06 cm STANDARD_DEVIATION 13.55 • n=7 Participants	113.93 cm STANDARD_DEVIATION 13.95 • n=5 Participants
Ankle/Brachial Index<0.90	64 Participants n=5 Participants	88 Participants n=7 Participants	152 Participants n=5 Participants
Hemoglobin A1c%	7.25 percentage of hemoglobin STANDARD_DEVIATION 1.14 • n=5 Participants	7.31 percentage of hemoglobin STANDARD_DEVIATION 1.20 • n=7 Participants	7.28 percentage of hemoglobin STANDARD_DEVIATION 1.17 • n=5 Participants
Fasting plasma glucose	152.19 mg/dl STANDARD_DEVIATION 44.71 • n=5 Participants	154.04 mg/dl STANDARD_DEVIATION 46.50 • n=7 Participants	153.12 mg/dl STANDARD_DEVIATION 45.6 • n=5 Participants
Plasma creatinine	0.82 mg/dl STANDARD_DEVIATION 0.20 • n=5 Participants	0.82 mg/dl STANDARD_DEVIATION 0.2 • n=7 Participants	0.82 mg/dl STANDARD_DEVIATION 0.2 • n=5 Participants
Total cholesterol	191.33 mg/dl STANDARD_DEVIATION 38.16 • n=5 Participants	190.65 mg/dl STANDARD_DEVIATION 37.04 • n=7 Participants	190.99 mg/dl STANDARD_DEVIATION 37.59 • n=5 Participants
LDL Cholesterol	112.36 mg/dl STANDARD_DEVIATION 32.21 • n=5 Participants	112.23 mg/dl STANDARD_DEVIATION 32.30 • n=7 Participants	112.29 mg/dl STANDARD_DEVIATION 32.25 • n=5 Participants
HDL Cholesterol	43.48 mg/dl STANDARD_DEVIATION 11.83 • n=5 Participants	43.47 mg/dl STANDARD_DEVIATION 11.81 • n=7 Participants	43.47 mg/dl STANDARD_DEVIATION 11.82 • n=5 Participants
Triglycerides	181.96 mg/dl STANDARD_DEVIATION 117.69 • n=5 Participants	179.94 mg/dl STANDARD_DEVIATION 117.92 • n=7 Participants	180.95 mg/dl STANDARD_DEVIATION 117.78 • n=5 Participants
Systolic blood pressure	128.19 mmHg STANDARD_DEVIATION 17.26 • n=5 Participants	129.45 mmHg STANDARD_DEVIATION 17.09 • n=7 Participants	128.82 mmHg STANDARD_DEVIATION 17.17 • n=5 Participants
Diastolic blood pressure	69.93 mmHg STANDARD_DEVIATION 9.55 • n=5 Participants	70.40 mmHg STANDARD_DEVIATION 9.72 • n=7 Participants	70.17 mmHg STANDARD_DEVIATION 9.63 • n=5 Participants
Duration of diabetes	6.77 years STANDARD_DEVIATION 6.66 • n=5 Participants	6.82 years STANDARD_DEVIATION 6.42 • n=7 Participants	6.80 years STANDARD_DEVIATION 6.54 • n=5 Participants
Maximal MET Value	7.21 kcal/kg/hour STANDARD_DEVIATION 1.95 • n=5 Participants	7.18 kcal/kg/hour STANDARD_DEVIATION 1.99 • n=7 Participants	7.19 kcal/kg/hour STANDARD_DEVIATION 1.97 • n=5 Participants
Maximal MET Value at 80% Heart Rate	5.17 kcal/kg/hour STANDARD_DEVIATION 1.53 • n=5 Participants	5.10 kcal/kg/hour STANDARD_DEVIATION 1.54 • n=7 Participants	5.13 kcal/kg/hour STANDARD_DEVIATION 1.53 • n=5 Participants
Metabolic syndrome	2387 Participants n=5 Participants	2415 Participants n=7 Participants	4802 Participants n=5 Participants
Family history of diabetes	1622 Participants n=5 Participants	1723 Participants n=7 Participants	3345 Participants n=5 Participants
History of Cardiovascular Disease (CVD)	373 Participants n=5 Participants	353 Participants n=7 Participants	726 Participants n=5 Participants
Hypertension	2063 Participants n=5 Participants	2069 Participants n=7 Participants	4132 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 11 years

Population: Intent to Treat, all randomized participants

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=2570 Participants Participants in the lifestyle intervention arm are offered individual and group sessions designed to help achieve and maintain weight loss. Lifestyle Intervention: The lifestyle intervention is implemented with individual supervision and group sessions and is aimed at achieving and maintaining at least a 7% decrease in weight from baseline and 175 minutes per week in physical activity. It is implemented during a four-year period with the most intensive application during the first year, less frequent attention during the next three years, and a minimum of twice yearly contacts during an extended follow-up period. To help participants achieve and maintain weight loss, a variety of diet strategies (e.g. prepared meals and liquid formula), exercise strategies, and optional weight loss medications are utilized based on a preset algorithm and participant progress.	Diabetes Support and Education n=2575 Participants The diabetes support and education arm provides group sessions on diabetes management and social support. Diabetes Support and Education: Participants assigned to diabetes support and education are offered three sessions each year in diabetes management and social support.
First Occurrence of a Severe Cardiovascular Event	403 Participants	418 Participants

SECONDARY outcome

Timeframe: up to 11 years

Population: Intent to treat, all randomized participants

Number of participants with first occurrence of one of the following: cardiovascular death, myocardial infarction (fatal or nonfatal), or stroke (fatal or non-fatal)

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=2570 Participants Participants in the lifestyle intervention arm are offered individual and group sessions designed to help achieve and maintain weight loss. Lifestyle Intervention: The lifestyle intervention is implemented with individual supervision and group sessions and is aimed at achieving and maintaining at least a 7% decrease in weight from baseline and 175 minutes per week in physical activity. It is implemented during a four-year period with the most intensive application during the first year, less frequent attention during the next three years, and a minimum of twice yearly contacts during an extended follow-up period. To help participants achieve and maintain weight loss, a variety of diet strategies (e.g. prepared meals and liquid formula), exercise strategies, and optional weight loss medications are utilized based on a preset algorithm and participant progress.	Diabetes Support and Education n=2575 Participants The diabetes support and education arm provides group sessions on diabetes management and social support. Diabetes Support and Education: Participants assigned to diabetes support and education are offered three sessions each year in diabetes management and social support.
First Occurrence of Cardiovascular Death, Myocardial Infarction, or Stroke	267 Participants	283 Participants

SECONDARY outcome

Timeframe: up to 11 years

Number of participants with first occurrence of one of the following: death (all causes), myocardial infarction, stroke, or hospitalizations for angina

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=2570 Participants Participants in the lifestyle intervention arm are offered individual and group sessions designed to help achieve and maintain weight loss. Lifestyle Intervention: The lifestyle intervention is implemented with individual supervision and group sessions and is aimed at achieving and maintaining at least a 7% decrease in weight from baseline and 175 minutes per week in physical activity. It is implemented during a four-year period with the most intensive application during the first year, less frequent attention during the next three years, and a minimum of twice yearly contacts during an extended follow-up period. To help participants achieve and maintain weight loss, a variety of diet strategies (e.g. prepared meals and liquid formula), exercise strategies, and optional weight loss medications are utilized based on a preset algorithm and participant progress.	Diabetes Support and Education n=2575 Participants The diabetes support and education arm provides group sessions on diabetes management and social support. Diabetes Support and Education: Participants assigned to diabetes support and education are offered three sessions each year in diabetes management and social support.
First Occurrence of Death, Myocardial Infarction, or Hospitalized Angina	496 Participants	529 Participants

SECONDARY outcome

Timeframe: up to 11 years

Population: Intent to treat, all randomized participants

Number of participants with first occurrence of one of the following: death (all causes), myocardial infarction, stroke, hospitalization for angina, coronary artery bypass grafting, percutaneous coronary angioplasty, hospitalization for congestive heart failure, carotid endarterectomy, or peripheral vascular procedures such as bypass or angioplasty

Outcome measures

Outcome measures
Measure	Lifestyle Intervention n=2570 Participants Participants in the lifestyle intervention arm are offered individual and group sessions designed to help achieve and maintain weight loss. Lifestyle Intervention: The lifestyle intervention is implemented with individual supervision and group sessions and is aimed at achieving and maintaining at least a 7% decrease in weight from baseline and 175 minutes per week in physical activity. It is implemented during a four-year period with the most intensive application during the first year, less frequent attention during the next three years, and a minimum of twice yearly contacts during an extended follow-up period. To help participants achieve and maintain weight loss, a variety of diet strategies (e.g. prepared meals and liquid formula), exercise strategies, and optional weight loss medications are utilized based on a preset algorithm and participant progress.	Diabetes Support and Education n=2575 Participants The diabetes support and education arm provides group sessions on diabetes management and social support. Diabetes Support and Education: Participants assigned to diabetes support and education are offered three sessions each year in diabetes management and social support.
First Occurrence of Major Clinical Events	577 Participants	600 Participants

Adverse Events

Lifestyle Intervention

Serious events: 639 serious events

Other events: 2493 other events

Deaths: 174 deaths

Diabetes Support and Education

Serious events: 596 serious events

Other events: 2488 other events

Deaths: 202 deaths

Serious adverse events

Serious adverse events
Measure	Lifestyle Intervention n=2570 participants at risk Participants in the lifestyle intervention arm are offered individual and group sessions designed to help achieve and maintain weight loss. Lifestyle Intervention: The lifestyle intervention is implemented with individual supervision and group sessions and is aimed at achieving and maintaining at least a 7% decrease in weight from baseline and 175 minutes per week in physical activity. It is implemented during a four-year period with the most intensive application during the first year, less frequent attention during the next three years, and a minimum of twice yearly contacts during an extended follow-up period. To help participants achieve and maintain weight loss, a variety of diet strategies (e.g. prepared meals and liquid formula), exercise strategies, and optional weight loss medications are utilized based on a preset algorithm and participant progress.	Diabetes Support and Education n=2575 participants at risk The diabetes support and education arm provides group sessions on diabetes management and social support. Diabetes Support and Education: Participants assigned to diabetes support and education are offered three sessions each year in diabetes management and social support.
Endocrine disorders Severe hypoglycemia	4.5% 115/2570 • Number of events 158 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.	4.7% 122/2575 • Number of events 150 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.
Gastrointestinal disorders Gall Stones	2.1% 53/2570 • Number of events 57 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.	1.9% 49/2575 • Number of events 52 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.
Musculoskeletal and connective tissue disorders All Fractures	17.7% 456/2570 • Number of events 596 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.	15.7% 404/2575 • Number of events 511 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.
Endocrine disorders Amputations	1.1% 28/2570 • Number of events 41 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.	0.78% 20/2575 • Number of events 28 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.
Cardiac disorders Congestive Heart Failure	3.0% 77/2570 • Number of events 112 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.	2.9% 75/2575 • Number of events 115 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.

Other adverse events

Other adverse events
Measure	Lifestyle Intervention n=2570 participants at risk Participants in the lifestyle intervention arm are offered individual and group sessions designed to help achieve and maintain weight loss. Lifestyle Intervention: The lifestyle intervention is implemented with individual supervision and group sessions and is aimed at achieving and maintaining at least a 7% decrease in weight from baseline and 175 minutes per week in physical activity. It is implemented during a four-year period with the most intensive application during the first year, less frequent attention during the next three years, and a minimum of twice yearly contacts during an extended follow-up period. To help participants achieve and maintain weight loss, a variety of diet strategies (e.g. prepared meals and liquid formula), exercise strategies, and optional weight loss medications are utilized based on a preset algorithm and participant progress.	Diabetes Support and Education n=2575 participants at risk The diabetes support and education arm provides group sessions on diabetes management and social support. Diabetes Support and Education: Participants assigned to diabetes support and education are offered three sessions each year in diabetes management and social support.
Cardiac disorders Chest pain/angina/heart pain	33.4% 858/2570 • Number of events 2299 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.	34.9% 899/2575 • Number of events 2444 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.
General disorders Abdominal pain, above and below	57.6% 1480/2570 • Number of events 4910 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.	59.0% 1520/2575 • Number of events 5374 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.
Gastrointestinal disorders Constipation	72.3% 1858/2570 • Number of events 8384 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.	71.4% 1838/2575 • Number of events 8095 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.
Gastrointestinal disorders Diarrhea	71.6% 1840/2570 • Number of events 7413 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.	73.6% 1896/2575 • Number of events 7968 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.
Cardiac disorders Dizzy or lightheaded, any	73.3% 1884/2570 • Number of events 8042 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.	73.2% 1886/2575 • Number of events 8177 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.
Cardiac disorders Swelling of the feet or ankles	68.9% 1770/2570 • Number of events 8511 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.	74.6% 1922/2575 • Number of events 9725 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.
Cardiac disorders Palpitations/heart racing/heart skipping beats	41.3% 1061/2570 • Number of events 3461 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.	45.4% 1169/2575 • Number of events 3806 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.
Musculoskeletal and connective tissue disorders Leg or arm pain during or following exercise	78.4% 2014/2570 • Number of events 8387 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.	77.9% 2006/2575 • Number of events 8100 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.
Musculoskeletal and connective tissue disorders Pulled or strained muscle, tendon, or ligament during or following exercise	59.9% 1540/2570 • Number of events 3886 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.	54.6% 1405/2575 • Number of events 3509 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.
General disorders Numbness or weakness of one arm or leg	57.6% 1480/2570 • Number of events 4821 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.	59.2% 1524/2575 • Number of events 5061 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.
Cardiac disorders Shortness of breath, any	72.1% 1852/2570 • Number of events 8669 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.	77.0% 1983/2575 • Number of events 9865 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.
Musculoskeletal and connective tissue disorders Swollen or sore joints during or following exercise	74.0% 1901/2570 • Number of events 7622 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.	74.7% 1923/2575 • Number of events 7626 • Up to 11 years Adverse events and serious adverse events are defined by the Food and Drug Administration and other governing bodies. All Look AHEAD participants were systematically queried at scheduled clinic visits or on clinic phone calls to capture outcome data on study outcomes, medical events, or adverse experiences. Severe hypoglycemia, gallstones, fractures, amputations, and congestive heart failure were monitored, as plausibly being affected by the intensive lifestyle intervention.

Additional Information

Dr. Mark Espeland, Principal Investigator

Wake Forest School of Medicine

Phone: 336-922-2072

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place