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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01780870
• Other study ID #: 2011P-000293
• Status: Active, not recruiting
• Phase: N/A
• First received: January 29, 2013
• Last updated: December 24, 2015
• Start date: September 2012
• Est. completion date: November 2017

Study information

• Verified date: December 2015
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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:

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

2. The impact of diet induced weight loss on leptin tolerance

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Body Weight
• Insulin Resistance
• Obesity
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be the difference in insulin and leptin tolerance after weight loss		8 weeks (10 ± 2% body weight reduction)	No
Secondary	Difference in brain signaling before and after the 10 ± 2% body weight reduction.	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	8 weeks (10 ± 2% body weight reduction)	No