Trial Outcomes & Findings for Insulin-sensitive Obesity: Lessons From Longitudinal Data (NCT NCT02017210)

NCT ID: NCT02017210

Last Updated: 2020-02-24

Results Overview

The change in insulin sensitivity (as measured by M-value normalised to insulin from hyperinsulinemic-euglycemic clamp) was determined "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart

• Recruitment status: COMPLETED
• Target enrollment: 57 participants
• Primary outcome timeframe: 6 years
• Results posted on: 2020-02-24

Participant Flow

Participant milestones

Measure	Lean/Normal Weight Individuals with BMI \< 25 kg/m\^2	Overweight/Obese Insulin-Sensitive Individuals with BMI \> 25 kg/m\^2 were categorised as Overweight/Obese Insulin-Sensitive if their M/I value was above the median M/I value for each gender	Overweight/Obese Insulin-Resistant Individuals with BMI \> 25 kg/m\^2 were categorised as Overweight/Obese Insulin-Resistant if their M/I were below the median M/I value for each gender
Overall Study STARTED	17	20	20
Overall Study COMPLETED	17	20	20
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Insulin-sensitive Obesity: Lessons From Longitudinal Data

Baseline characteristics by cohort

Measure	Lean/Normal Weight n=17 Participants Individuals with body mass index (BMI)\<25 kg/m\^2 in the baseline study	Overweight/Obese Insulin-Sensitive n=20 Participants Individuals with BMI\>25 kg/m\^2 who were deemed insulin-sensitive at the baseline study	Overweight/Obese Insulin-Resistant n=20 Participants Individuals with BMI\>25 kg/m\^2 who were deemed insulin-resistant at the baseline study	Total n=57 Participants Total of all reporting groups
Age, Continuous	54.6 years STANDARD_DEVIATION 11.1 • n=5 Participants	54.2 years STANDARD_DEVIATION 10.7 • n=7 Participants	63.4 years STANDARD_DEVIATION 10.7 • n=5 Participants	57.5 years STANDARD_DEVIATION 11.6 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants	27 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	11 Participants n=7 Participants	8 Participants n=5 Participants	30 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	54 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Australia	17 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	99 Participants n=4 Participants

PRIMARY outcome

Timeframe: 6 years

Population: The hyperinsulinemic-euglycemic clamp was performed in a sub-cohort of n=9, 10 and 16 participants who were normal-weight, overweight/obese insulin-sensitive and overweight/obese insulin-resistant, respectively

The change in insulin sensitivity (as measured by M-value normalised to insulin from hyperinsulinemic-euglycemic clamp) was determined "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart

Outcome measures

Measure	Lean/Normal Weight n=9 Participants Individuals with BMI\<25 kg/m2 at the baseline study	Overweight/Obese Insulin-Sensitive n=10 Participants Individuals with BMI\>25 kg/m2 who were deemed insulin-sensitive at the baseline study	Overweight/Obese Insulin-Resistant n=16 Participants Individuals with BMI\>25 kg/m2 who were deemed insulin-resistant at the baseline study
Insulin Sensitivity	0.0105 micro mol/min/Kg/mU/L/year Interval -0.0202 to 0.0163	-0.0076 micro mol/min/Kg/mU/L/year Interval -0.038 to 0.0073	0.0041 micro mol/min/Kg/mU/L/year Interval -0.0022 to 0.0109

SECONDARY outcome

Timeframe: 6 years

Population: All individuals who were followed up after 6 years were analyzed

Change in body mass index (BMI) was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart

Outcome measures

Measure	Lean/Normal Weight n=17 Participants Individuals with BMI\<25 kg/m2 at the baseline study	Overweight/Obese Insulin-Sensitive n=20 Participants Individuals with BMI\>25 kg/m2 who were deemed insulin-sensitive at the baseline study	Overweight/Obese Insulin-Resistant n=20 Participants Individuals with BMI\>25 kg/m2 who were deemed insulin-resistant at the baseline study
Body Mass Index	0.0526 kg/m^2/year Interval -0.0179 to 0.2842	0.0941 kg/m^2/year Interval -0.0762 to 0.3689	0.0088 kg/m^2/year Interval -0.1867 to 0.2309

SECONDARY outcome

Timeframe: 6 years

Population: All individuals who were followed up after 6 years were analyzed

Change in waist circumference was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart

Outcome measures

Measure	Lean/Normal Weight n=17 Participants Individuals with BMI\<25 kg/m2 at the baseline study	Overweight/Obese Insulin-Sensitive n=20 Participants Individuals with BMI\>25 kg/m2 who were deemed insulin-sensitive at the baseline study	Overweight/Obese Insulin-Resistant n=20 Participants Individuals with BMI\>25 kg/m2 who were deemed insulin-resistant at the baseline study
Waist Circumference	0.5263 cm/year Interval -0.1924 to 1.206	0.4894 cm/year Interval -0.6522 to 1.1917	0.0000 cm/year Interval -1.0812 to 0.6588

SECONDARY outcome

Timeframe: 6 years

Population: DXA was performed in a sub-cohort of n=11, 11 and 19 in normal weight, overweight/obese insulin-sensitive and overweight/obese insulin-resistant participants, respectively

Body fat mass from dual-energy X-ray absorptiometry (DXA) change was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart

Outcome measures

Measure	Lean/Normal Weight n=11 Participants Individuals with BMI\<25 kg/m2 at the baseline study	Overweight/Obese Insulin-Sensitive n=11 Participants Individuals with BMI\>25 kg/m2 who were deemed insulin-sensitive at the baseline study	Overweight/Obese Insulin-Resistant n=19 Participants Individuals with BMI\>25 kg/m2 who were deemed insulin-resistant at the baseline study
Body Fat Mass	0.2281 % of total body mass/year Interval -0.2256 to 0.8134	0.3696 % of total body mass/year Interval 0.1465 to 0.5812	0.3478 % of total body mass/year Interval -0.0303 to 0.5745

SECONDARY outcome

Timeframe: 6 years

Population: DXA was performed in a sub-cohort of n=11, 11 and 19 in normal weight, overweight/obese insulin-sensitive and overweight/obese insulin-resistant participants, respectively

Body fat-free mass (FFM) from DXA change was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart

Outcome measures

Measure	Lean/Normal Weight n=11 Participants Individuals with BMI\<25 kg/m2 at the baseline study	Overweight/Obese Insulin-Sensitive n=11 Participants Individuals with BMI\>25 kg/m2 who were deemed insulin-sensitive at the baseline study	Overweight/Obese Insulin-Resistant n=19 Participants Individuals with BMI\>25 kg/m2 who were deemed insulin-resistant at the baseline study
Body FFM	-0.0382 kg/year Interval -0.293 to 0.0771	-0.1786 kg/year Interval -0.3613 to 0.0333	-0.4017 kg/year Interval -0.7577 to 0.0277

SECONDARY outcome

Timeframe: 6 years

Population: Visceral fat volume was available in n=11, 10 and 18 normal weight, overweight/obese insulin-sensitive and overweight/obese insulin-resistant participants who undergone a DXA measure due to technical reasons

Abdominal visceral fat volume from DXA change was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart

Outcome measures

Measure	Lean/Normal Weight n=11 Participants Individuals with BMI\<25 kg/m2 at the baseline study	Overweight/Obese Insulin-Sensitive n=10 Participants Individuals with BMI\>25 kg/m2 who were deemed insulin-sensitive at the baseline study	Overweight/Obese Insulin-Resistant n=18 Participants Individuals with BMI\>25 kg/m2 who were deemed insulin-resistant at the baseline study
Visceral Fat Volume	13.3962 cm^3/year Interval -2.3225 to 75.3947	47.3351 cm^3/year Interval -12.6 to 94.9231	46.2974 cm^3/year Interval 27.1212 to 113.1915

SECONDARY outcome

Timeframe: 6 years

Population: All individuals who were followed up after 6 years were analyzed

Change in Systolic Blood Pressure was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart

Outcome measures

Measure	Lean/Normal Weight n=17 Participants Individuals with BMI\<25 kg/m2 at the baseline study	Overweight/Obese Insulin-Sensitive n=20 Participants Individuals with BMI\>25 kg/m2 who were deemed insulin-sensitive at the baseline study	Overweight/Obese Insulin-Resistant n=20 Participants Individuals with BMI\>25 kg/m2 who were deemed insulin-resistant at the baseline study
Systolic Blood Pressure	0.3704 mmHg/year Interval -0.3548 to 2.8373	0.9483 mmHg/year Interval -1.2137 to 2.5466	1.3593 mmHg/year Interval -0.1087 to 4.1122

SECONDARY outcome

Timeframe: 6 years

Population: All individuals who were followed up after 6 years were analyzed

Change in Diastolic Blood Pressure was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart

Outcome measures

Measure	Lean/Normal Weight n=17 Participants Individuals with BMI\<25 kg/m2 at the baseline study	Overweight/Obese Insulin-Sensitive n=20 Participants Individuals with BMI\>25 kg/m2 who were deemed insulin-sensitive at the baseline study	Overweight/Obese Insulin-Resistant n=20 Participants Individuals with BMI\>25 kg/m2 who were deemed insulin-resistant at the baseline study
Diastolic Blood Pressure	1.1290 mmHg/year Interval -0.3792 to 2.8535	0.4117 mmHg/year Interval -0.1567 to 1.3193	0.5662 mmHg/year Interval -0.3191 to 1.9224

SECONDARY outcome

Timeframe: 6 years

Population: Fasting blood glucose concentration measure was available in a sub-cohort of n=16, 18 and 19 in normal weight, overweight/obese insulin-sensitive and overweight/obese insulin-resistant participants, respectively

Change in fasting blood glucose was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart

Outcome measures

Measure	Lean/Normal Weight n=16 Participants Individuals with BMI\<25 kg/m2 at the baseline study	Overweight/Obese Insulin-Sensitive n=18 Participants Individuals with BMI\>25 kg/m2 who were deemed insulin-sensitive at the baseline study	Overweight/Obese Insulin-Resistant n=19 Participants Individuals with BMI\>25 kg/m2 who were deemed insulin-resistant at the baseline study
Fasting Blood Glucose	-0.0151 mmol/L/year Interval -0.0429 to 0.05	0.0062 mmol/L/year Interval -0.0333 to 0.0373	-0.0254 mmol/L/year Interval -0.0962 to 0.0512

SECONDARY outcome

Timeframe: 6 years

Population: Fasting serum insulin measurement was available in a sub-cohort of n=16, 18 and 19 in normal weight, overweight/obese insulin-sensitive and overweight/obese insulin-resistant participants, respectively

Change in fasting serum insulin was determined as "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart

Outcome measures

Measure	Lean/Normal Weight n=16 Participants Individuals with BMI\<25 kg/m2 at the baseline study	Overweight/Obese Insulin-Sensitive n=18 Participants Individuals with BMI\>25 kg/m2 who were deemed insulin-sensitive at the baseline study	Overweight/Obese Insulin-Resistant n=19 Participants Individuals with BMI\>25 kg/m2 who were deemed insulin-resistant at the baseline study
Fasting Serum Insulin	0.2223 mU/L/year Interval -0.7104 to 1.294	0.0855 mU/L/year Interval -0.6545 to 0.4863	-0.2370 mU/L/year Interval -1.8802 to 0.5054

Adverse Events

Lean/Normal Weight

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Overweight/Obese Insulin-Sensitive

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Overweight/Obese Insulin-Resistant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Dorit Samocha-Bonet

Garvan Institute of Medical Research

Phone: +61292958309

Email: d.samochabonet@garvan.org.au

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place