Trial Outcomes & Findings for Weight Loss Study-Mechanism Underlying the Improvement of Insulin Resistance in Response to Weight Loss (NCT NCT01780870)

Results Overview

The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

8 weeks

Results posted on

2017-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	Control Group Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy	Weight Loss Group Full Meal replacement Protocol Weight loss group (Full meal replacement products): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase
Overall Study STARTED	0	5
Overall Study COMPLETED	0	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Weight Loss Study-Mechanism Underlying the Improvement of Insulin Resistance in Response to Weight Loss

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy	Weight Loss Group n=5 Participants Full Meal replacement Protocol Weight loss group (Full meal replacement products): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	5 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	—	32.8 years STANDARD_DEVIATION 3.1 • n=7 Participants	32.8 years STANDARD_DEVIATION 3.1 • n=5 Participants
Sex: Female, Male Female	—	5 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	—	5 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment

Outcome measures

Outcome measures
Measure	Control Group Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy	Weight Loss Group n=5 Participants Full Meal replacement Protocol Weight loss group (Full meal replacement products): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase
The Primary Outcome Will be the Leptin Levels at Baseline and 8 Weeks Baseline Leptin	—	39.5 ng/ml Standard Deviation 7.7
The Primary Outcome Will be the Leptin Levels at Baseline and 8 Weeks Week 8 Leptin	—	13.4 ng/ml Standard Deviation 1.6

PRIMARY outcome

Timeframe: 8 weeks

The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment

Outcome measures

Outcome measures
Measure	Control Group Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy	Weight Loss Group n=5 Participants Full Meal replacement Protocol Weight loss group (Full meal replacement products): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase
The Primary Outcome Will be Insulin Levels at Baseline and 8 Weeks Baseline Insulin	—	13 μU/ml Standard Deviation 1.6
The Primary Outcome Will be Insulin Levels at Baseline and 8 Weeks Week 8 Insulin	—	6.4 μU/ml Standard Deviation 1.4

PRIMARY outcome

Timeframe: 8 weeks

The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment

Outcome measures

Outcome measures
Measure	Control Group Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy	Weight Loss Group n=5 Participants Full Meal replacement Protocol Weight loss group (Full meal replacement products): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase
The Primary Outcome Will be HOMA-IR at Baseline and 8 Weeks Baseline HOMA-IR	—	2.82 HOMA score Standard Deviation 0.37
The Primary Outcome Will be HOMA-IR at Baseline and 8 Weeks Week 8 HOMA-IR	—	1.33 HOMA score Standard Deviation 0.31

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Weight Loss Group

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. Christos Mantzoros

Beth Israel Deaconess Medical Center

Phone: 6176678633

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place