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

May 1, 2017 updated by: Christos Mantzoros, Beth Israel Deaconess Medical Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria for interventional group:

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

Inclusion Criteria for control group:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
Active Comparator: Weight loss group
Full Meal replacement Protocol
Dietary supplement: 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
Other Names:
  • Full meal replacement products (1280-1320 kcal/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks
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
8 weeks
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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Investigators

  • Principal Investigator: Christos Mantzoros, MD, Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

January 29, 2013

First Submitted That Met QC Criteria

January 30, 2013

First Posted (Estimate)

January 31, 2013

Study Record Updates

Last Update Posted (Actual)

August 7, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011P000293

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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