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Valued EpiGenetic Glycemic ImprovEments Through Weight Loss

NCT02869659 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2020-12-31

No results posted yet for this study

Summary

This randomized controlled clinical trial will use methylomic and transcriptomic profiling to examine the effects of a weight loss intervention on the cholesterol metabolism gene network in monocytes and adipocytes and investigate the longitudinal relationship between these modifications and glycemic improvements.

Conditions

Interventions

BEHAVIORAL

Weight Loss Group

All participants will follow the Medifast Achieve TM 4 \& 2 \& 1 Plan® which includes the 4 MR products per day, with the addition of 2 Lean and Green™ Meals and 1 Healthy Snack

BEHAVIORAL

Delayed Weight Loss

18 weekly, group dietary and exercise sessions led by the study staff in which participants will follow a modified Diabetes Prevention Program

Sponsors & Collaborators

  • Medifast, Inc.

    collaborator INDUSTRY

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Jingzhong Ding, PhD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-01
Primary Completion
2020-07-29
Completion
2020-12-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02869659 on ClinicalTrials.gov