CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5 enrolled
Drug / intervention
Weight loss group (Full meal replacement products)dietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01780870
NCT01780870N/ACompleted

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

Beth Israel Deaconess Medical Center·interventional·Posted Jan 31, 2013·Updated Aug 7, 2017

In Brief

A clinical study evaluating Weight loss group (Full meal replacement products) for Obesity and Weight Loss. Completed, enrolled 5 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Weight Loss
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 31, 2013
Enrollment StartSep 1, 2012
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 13.4 years ago

Interventions

Weight loss group (Full meal replacement products)dietary

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