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

The main purpose of this study is to assess factors mediating the changes in insulin sensitivity and glucose tolerance before and after 10 lbs ± or 2% weight loss reduction as well as 2, 3, 6, 12, and 24 months after initiation of a low calorie diet.

The investigators will also study the following:

1. The impact of diet induced weight loss on hormones/adipokine levels 2. The impact of diet induced weight loss on leptin tolerance

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for interventional group:

Adult men and women, age 18-50
English speaking
Body mass index (pre weight loss) ≥30 kg/m2 but <40 kg/m2
Willing to enroll in a low calorie full meal replacement weight loss program
Willing and able to take part in a multi year study involving visits

Inclusion criteria

for control group:

Adult men and women, age 18-50
English speaking
Body mass index (pre weight loss) ≥30 kg/m2 but <40 kg/m2
Willing and able to take part in a multi year study involving visits

Treatment and study plan

Weight loss group (Full meal replacement products)

Dietary Supplement

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

Other names: Full meal replacement products (1280-1320 kcal/day)

Primary outcomes

The Primary Outcome Will be the Leptin Levels at Baseline and 8 Weeks

Time frame: 8 weeks

The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment
The Primary Outcome Will be Insulin Levels at Baseline and 8 Weeks

Time frame: 8 weeks

The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment
The Primary Outcome Will be HOMA-IR at Baseline and 8 Weeks

Time frame: 8 weeks

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

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2017
First posted: Jan 31, 2013
Registry last updated: Aug 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed