Trial Outcomes & Findings for EMPOWIR:Enhance the Metabolic Profile of Women With Insulin Resistance (NCT NCT00618072)
NCT ID: NCT00618072
Last Updated: 2014-03-28
Results Overview
Insulin was determined with a Siemens Immulite assay with respective intra-and inter-CV's 5.7 and 5.9%, and no cross reactivity to pro-insulin.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
6 months
Results posted on
2014-03-28
Participant Flow
Patients were enrolled from December 2007 until November 2010. The study was conducted at two academic medical centers: Montefiore Hospital/Einstein, Bronx, and Westchester Medical Center/New York Medical College, Valhalla, NY in conjunction with the GCRC at Einstein.
Prior to randomization, subjects attended 4 weekly workshops to introduce study instruments \& the EMPOWIR diet -a food exchange program promoting intake of vegetables, low-glycemic index fruits, low-fat protein \& dairy products, elimination of added sugars \& the notable restriction of 3 additional allowable carbohydrates to after 4PM.
Participant milestones
| Measure |
A: EMPOWIR Diet and Placebo
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
B: EMPOWIR Diet Plus Metformin and Placebo Avandia
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
C: EMPOWIR Diet Plus Metformin and Avandia
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
14
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
4
|
Reasons for withdrawal
| Measure |
A: EMPOWIR Diet and Placebo
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
B: EMPOWIR Diet Plus Metformin and Placebo Avandia
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
C: EMPOWIR Diet Plus Metformin and Avandia
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
Baseline Characteristics
EMPOWIR:Enhance the Metabolic Profile of Women With Insulin Resistance
Baseline characteristics by cohort
| Measure |
A: EMPOWIR Diet and Placebo
n=16 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day
|
B: EMPOWIR Diet Plus Metformin and Placebo Avandia
n=15 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day
|
C: EMPOWIR Diet Plus Metformin and Avandia
n=15 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
46 participants
n=4 Participants
|
|
Fasting insulin
|
11.2 uIU/mL
STANDARD_DEVIATION 1.4 • n=5 Participants
|
12.5 uIU/mL
STANDARD_DEVIATION 2.0 • n=7 Participants
|
8.7 uIU/mL
STANDARD_DEVIATION 1.5 • n=5 Participants
|
10.7 uIU/mL
STANDARD_DEVIATION 0.7 • n=4 Participants
|
|
Body Weight
|
84.1 kg
STANDARD_DEVIATION 2.8 • n=5 Participants
|
85.1 kg
STANDARD_DEVIATION 2.4 • n=7 Participants
|
81.8 kg
STANDARD_DEVIATION 3.2 • n=5 Participants
|
82.4 kg
STANDARD_DEVIATION 1.63 • n=4 Participants
|
|
HOMA-IR
|
2.3 HOMA-IR score
STANDARD_DEVIATION 0.2 • n=5 Participants
|
2.5 HOMA-IR score
STANDARD_DEVIATION 0.4 • n=7 Participants
|
1.9 HOMA-IR score
STANDARD_DEVIATION 0.3 • n=5 Participants
|
2.3 HOMA-IR score
STANDARD_DEVIATION 0.2 • n=4 Participants
|
|
Waist circumference
|
97.5 cm
STANDARD_DEVIATION 2.3 • n=5 Participants
|
92.9 cm
STANDARD_DEVIATION 1.8 • n=7 Participants
|
93.1 cm
STANDARD_DEVIATION 2.1 • n=5 Participants
|
94.7 cm
STANDARD_DEVIATION 1.27 • n=4 Participants
|
|
Systolic BP
|
117.5 mmHg
STANDARD_DEVIATION 2.9 • n=5 Participants
|
114.3 mmHg
STANDARD_DEVIATION 3.4 • n=7 Participants
|
118.7 mmHg
STANDARD_DEVIATION 6.0 • n=5 Participants
|
118.2 mmHg
STANDARD_DEVIATION 2.1 • n=4 Participants
|
|
Diastolic BP
|
75.9 mmHg
STANDARD_DEVIATION 2.6 • n=5 Participants
|
75.3 mmHg
STANDARD_DEVIATION 2.0 • n=7 Participants
|
76.9 mmHg
STANDARD_DEVIATION 4.2 • n=5 Participants
|
75.4 mmHg
STANDARD_DEVIATION 1.4 • n=4 Participants
|
|
HDL
|
49.3 mg/dl
STANDARD_DEVIATION 2.3 • n=5 Participants
|
61.6 mg/dl
STANDARD_DEVIATION 5.7 • n=7 Participants
|
60.1 mg/dl
STANDARD_DEVIATION 3.2 • n=5 Participants
|
58.9 mg/dl
STANDARD_DEVIATION 2.4 • n=4 Participants
|
|
Triglycerides
|
90.1 mg/dl
STANDARD_DEVIATION 9.5 • n=5 Participants
|
88.0 mg/dl
STANDARD_DEVIATION 11.3 • n=7 Participants
|
82.6 mg/dl
STANDARD_DEVIATION 11.2 • n=5 Participants
|
86.9 mg/dl
STANDARD_DEVIATION 9.3 • n=4 Participants
|
|
Adiponectin
|
9.3 ug/mL
STANDARD_DEVIATION 1.3 • n=5 Participants
|
10.6 ug/mL
STANDARD_DEVIATION 1.4 • n=7 Participants
|
11.1 ug/mL
STANDARD_DEVIATION 1.0 • n=5 Participants
|
10.6 ug/mL
STANDARD_DEVIATION 4.6 • n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The final data-set consisted of 44 study participants, after exclusion of two study completers due to clinical conditions which appeared de novo (asthma requiring high dose prednisone and growth hormone deficiency diagnosed mid-study) - applicable to all study outcomes.
Insulin was determined with a Siemens Immulite assay with respective intra-and inter-CV's 5.7 and 5.9%, and no cross reactivity to pro-insulin.
Outcome measures
| Measure |
A: EMPOWIR Diet and Placebo
n=16 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
B: EMPOWIR Diet Plus Metformin and Placebo Avandia
n=14 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
C: EMPOWIR Diet Plus Metformin and Avandia
n=14 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
|---|---|---|---|
|
Fasting Insulin
|
8.1 uIU/mL
Standard Error 1.3
|
8.0 uIU/mL
Standard Error 1.2
|
6.3 uIU/mL
Standard Error 0.9
|
SECONDARY outcome
Timeframe: 6 monthsBody weight measurement was performed three times and averaged by a single study coordinator.
Outcome measures
| Measure |
A: EMPOWIR Diet and Placebo
n=16 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
B: EMPOWIR Diet Plus Metformin and Placebo Avandia
n=14 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
C: EMPOWIR Diet Plus Metformin and Avandia
n=14 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
|---|---|---|---|
|
Body Weight
|
80.0 kg
Standard Error 2.7
|
80.4 kg
Standard Error 2.1
|
77.5 kg
Standard Error 4.0
|
SECONDARY outcome
Timeframe: 6 monthsHOMA-IR was calculated by the formula: fasting insulin (uU/mL) times fasting glucose (mg/L) divided by 22.5.
Outcome measures
| Measure |
A: EMPOWIR Diet and Placebo
n=16 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
B: EMPOWIR Diet Plus Metformin and Placebo Avandia
n=14 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
C: EMPOWIR Diet Plus Metformin and Avandia
n=14 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
|---|---|---|---|
|
HOMA-IR
|
1.5 HOMA-IR score
Standard Error 0.1
|
1.6 HOMA-IR score
Standard Error 0.3
|
1.3 HOMA-IR score
Standard Error 0.2
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
A: EMPOWIR Diet and Placebo
n=16 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
B: EMPOWIR Diet Plus Metformin and Placebo Avandia
n=14 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
C: EMPOWIR Diet Plus Metformin and Avandia
n=14 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
|---|---|---|---|
|
Waist Circumference
|
93.1 cm
Standard Error 2.1
|
90.4 cm
Standard Error 1.9
|
87.5 cm
Standard Error 3.2
|
SECONDARY outcome
Timeframe: 6 monthsBlood pressure was assessed using NCEP guidelines.
Outcome measures
| Measure |
A: EMPOWIR Diet and Placebo
n=16 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
B: EMPOWIR Diet Plus Metformin and Placebo Avandia
n=14 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
C: EMPOWIR Diet Plus Metformin and Avandia
n=14 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
|---|---|---|---|
|
Systolic BP
|
113.8 mmHg
Standard Error 2.9
|
107.2 mmHg
Standard Error 3.0
|
114.2 mmHg
Standard Error 4.7
|
SECONDARY outcome
Timeframe: 6 monthsBlood pressure was assessed using NCEP guidelines.
Outcome measures
| Measure |
A: EMPOWIR Diet and Placebo
n=16 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
B: EMPOWIR Diet Plus Metformin and Placebo Avandia
n=14 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
C: EMPOWIR Diet Plus Metformin and Avandia
n=14 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
|---|---|---|---|
|
Diastolic BP
|
71.7 mmHg
Standard Error 2.3
|
72.7 mmHg
Standard Error 2.3
|
74.3 mmHg
Standard Error 3.8
|
SECONDARY outcome
Timeframe: 6 monthsHDL was measured using two reagents homogeneous systems with selective detergents to homogenize the lipoprotein of interest.
Outcome measures
| Measure |
A: EMPOWIR Diet and Placebo
n=16 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
B: EMPOWIR Diet Plus Metformin and Placebo Avandia
n=14 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
C: EMPOWIR Diet Plus Metformin and Avandia
n=14 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
|---|---|---|---|
|
HDL
|
56.5 mg/dl
Standard Error 3.5
|
70.1 mg/dl
Standard Error 5.8
|
68.3 mg/dl
Standard Error 6.2
|
SECONDARY outcome
Timeframe: 6 monthsTriglycerides were measured by enzymatic immunoassay on an AU400 chemistry auto-analyzer with commercially available enzymatic reagents.
Outcome measures
| Measure |
A: EMPOWIR Diet and Placebo
n=16 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
B: EMPOWIR Diet Plus Metformin and Placebo Avandia
n=14 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
C: EMPOWIR Diet Plus Metformin and Avandia
n=14 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
|---|---|---|---|
|
Triglycerides
|
95.2 mg/dl
Standard Error 10.7
|
103.1 mg/dl
Standard Error 13.0
|
109.2 mg/dl
Standard Error 18.3
|
SECONDARY outcome
Timeframe: 6 monthsTotal adiponectin was measured with a commercial ELISA kit (Millipore/Linco Research, St. Charles, MO) in the laboratory of Dr. Philipp Scherer.
Outcome measures
| Measure |
A: EMPOWIR Diet and Placebo
n=16 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
B: EMPOWIR Diet Plus Metformin and Placebo Avandia
n=14 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
C: EMPOWIR Diet Plus Metformin and Avandia
n=14 Participants
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
|
|---|---|---|---|
|
Adiponectin
|
10.6 ug/mL
Standard Error 1.2
|
10.9 ug/mL
Standard Error 1.7
|
18.5 ug/mL
Standard Error 1.5
|
Adverse Events
A: EMPOWIR and Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
B: EMPOWIR Diet Plus Metformin and Placebo Avandia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
C: EMPOWIR Diet Plus Metformin and Avandia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A: EMPOWIR and Placebo
n=16 participants at risk
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
|
B: EMPOWIR Diet Plus Metformin and Placebo Avandia
n=15 participants at risk
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone placebo 2mg/day added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
|
C: EMPOWIR Diet Plus Metformin and Avandia
n=15 participants at risk
EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
|
|---|---|---|---|
|
Cardiac disorders
Worsening of Hypertension
|
6.2%
1/16 • Number of events 1
|
0.00%
0/15
|
0.00%
0/15
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place