search
Back to results

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

Primary Purpose

Obesity, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight loss group (Full meal replacement products)
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Overweight, Obesity, Obese, Weight loss

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control Group

Weight loss group

Arm Description

Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy

Full Meal replacement Protocol

Outcomes

Primary Outcome Measures

The Primary Outcome Will be the Leptin Levels at Baseline and 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
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
The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment

Secondary Outcome Measures

Full Information

First Posted
January 29, 2013
Last Updated
May 1, 2017
Sponsor
Beth Israel Deaconess Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01780870
Brief Title
Weight Loss Study-Mechanism Underlying the Improvement of Insulin Resistance in Response to Weight Loss
Official Title
Weight Loss Study-Mechanism Underlying the Improvement of Insulin Resistance in Response to Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
Keywords
Overweight, Obesity, Obese, Weight loss

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy
Arm Title
Weight loss group
Arm Type
Active Comparator
Arm Description
Full Meal replacement Protocol
Intervention Type
Dietary Supplement
Intervention Name(s)
Weight loss group (Full meal replacement products)
Other Intervention Name(s)
Full meal replacement products (1280-1320 kcal/day)
Intervention Description
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
Primary Outcome Measure Information:
Title
The Primary Outcome Will be the Leptin Levels at Baseline and 8 Weeks
Description
The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment
Time Frame
8 weeks
Title
The Primary Outcome Will be Insulin Levels at Baseline and 8 Weeks
Description
The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment
Time Frame
8 weeks
Title
The Primary Outcome Will be HOMA-IR at Baseline and 8 Weeks
Description
The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christos Mantzoros, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs