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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01780870
First Posted: January 31, 2013
Last Update Posted: August 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christos Mantzoros, Beth Israel Deaconess Medical Center
  Purpose

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

Condition Intervention
Obesity Weight Loss Dietary Supplement: Weight loss group (Full meal replacement products)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Weight Loss Study-Mechanism Underlying the Improvement of Insulin Resistance in Response to Weight Loss

Resource links provided by NLM:


Further study details as provided by Christos Mantzoros, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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


Enrollment: 5
Study Start Date: September 2012
Study Completion Date: January 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Full meal replacement products (1280-1320 kcal/day)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01780870


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Christos Mantzoros, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Christos Mantzoros, Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01780870     History of Changes
Other Study ID Numbers: 2011P000293
First Submitted: January 29, 2013
First Posted: January 31, 2013
Results First Submitted: January 6, 2017
Results First Posted: August 7, 2017
Last Update Posted: August 7, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Christos Mantzoros, Beth Israel Deaconess Medical Center:
Overweight
Obesity
Obese
Weight loss

Additional relevant MeSH terms:
Body Weight
Weight Loss
Insulin Resistance
Signs and Symptoms
Body Weight Changes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs