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

This study is currently recruiting participants.

Verified February 2013 by Beth Israel Deaconess Medical Center

Sponsor:

Information provided by (Responsible Party):

Beth Israel Deaconess Medical Center

ClinicalTrials.gov Identifier:

NCT01780870

First received: January 29, 2013

Last updated: February 19, 2013

Last verified: February 2013

History of Changes

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:

The impact of diet induced weight loss on hormones/adipokine levels
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: 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:

MedlinePlus related topics: Diabetes Medicines Obesity Weight Control

Drug Information available for: Insulin human

U.S. FDA Resources

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

Primary Outcome Measures:

The primary outcome will be the difference in insulin and leptin tolerance after weight loss [ Time Frame: 8 weeks (10 ± 2% body weight reduction) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Difference in brain signaling before and after the 10 ± 2% body weight reduction. [ Time Frame: 8 weeks (10 ± 2% body weight reduction) ] [ Designated as safety issue: No ]
We will examine the impact of weight loss on human brain responses to food visualization using functional magnetic resonance imaging (fMRI) and assess whether the baseline CNS signaling has any effect on the ability to lose and maintain weight

Estimated Enrollment:	30
Study Start Date:	September 2012
Estimated Study Completion Date:	March 2015
Estimated Primary Completion Date:	March 2013 (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)

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

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780870

Contacts

Contact: Christos Mantzoros, MD

617-667-8630

mantzlab@bidmc.harvard.edu

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Christos Mantzoros, MD 617-667-8630 mantzlab@bidmc.harvard.edu
Principal Investigator: Christos Mantzoros, MD

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator:

Christos Mantzoros, MD

Beth Israel Deaconess Medical Center

More Information

No publications provided

Responsible Party:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT01780870 History of Changes
Other Study ID Numbers:	2011P-000293
Study First Received:	January 29, 2013
Last Updated:	February 19, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

Overweight
Obesity
Obese
Weight loss

Additional relevant MeSH terms:

Insulin Resistance
Obesity
Weight Loss
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 23, 2013

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