MedTrace Logo

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

NCT01780870 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2017-08-07

Study results available
· View outcomes & findings →

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

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Christos Mantzoros, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01780870 on ClinicalTrials.gov