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

Tracking Information

First Received Date ^ICMJE

January 29, 2013

Last Updated Date

February 19, 2013

Start Date ^ICMJE

September 2012

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01780870 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Obesity
Weight Loss

Intervention ^ICMJE

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)

Study Arm (s)

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

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2015

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Christos Mantzoros, MD

617-667-8630

mantzlab@bidmc.harvard.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01780870

Other Study ID Numbers ^ICMJE

2011P-000293

Has Data Monitoring Committee

Yes

Responsible Party

Beth Israel Deaconess Medical Center

Study Sponsor ^ICMJE

Beth Israel Deaconess Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Christos Mantzoros, MD

Beth Israel Deaconess Medical Center

Information Provided By

Beth Israel Deaconess Medical Center

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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