Valued EpiGenetic Glycemic ImprovEments Through Weight Loss (VEGGIE)
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|ClinicalTrials.gov Identifier: NCT02869659|
Recruitment Status : Recruiting
First Posted : August 17, 2016
Last Update Posted : July 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obesity Pre-diabetes||Behavioral: Weight Loss Group Behavioral: Delayed Weight Loss||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Valued EpiGenetic Glycemic ImprovEments Through Weight Loss|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Active Comparator: Control/Delayed Weight Loss Group
Control/Delayed Weight Loss Group: (18 weeks) Participants randomized to the delayed weight loss intervention (n=100) will serve as a no-weight loss control to the weight loss group during the first 18 weeks of the study. During the control (18 weeks) phase these participants will receive a monthly phone call visit from staff to maintain contact and interest in the study. At the end of the initial 18 weeks participants will complete all follow up assessments prior to being offered the opportunity to participate in a weight loss program.
No outcome data will be collected at the end of the delayed weight loss phase.
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
Experimental: Weight Loss Group
Weight Loss group: Phase 1 (18 wks): Participants assigned to this group will undergo a dietary intervention for the first 18 weeks of the study.
This level of weight loss will be achieved through the combination of a partial meal replacement (MR) program and individual and group nutrition/behavioral counseling. Participants will be provided with and asked to consume 4 Medifast® MR per day.
Phase 2 (8 wks): After completion of the active weight loss phase, participants in this group will attend bimonthly group meetings to discuss increasing their activity.
Phase 3 (26 wks): After completion of phase 2, participants will be called monthly for 26 weeks and then asked to return for a maintenance visit at the end of the 52 weeks from study start.
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
- Chang in Epigengene score (and related individual transcriptional and methylation measures) [ Time Frame: baseline and 18 weeks ]The eigengene score is defined as the first principal component of a transcriptional network.
- change in glucose tolerance [ Time Frame: baseline and 18 weeks ]A 2-hr OGTT will be performed to assess changes in glucose tolerance and insulin responses to the glucose challenge. Blood samples will be drawn before and after (30, 60, 90, and 120 min) a 75-g glucose ingestion for the determination of plasma glucose and insulin.
- change in homeostatic model assessment (HOMA) estimates of insulin resistance [ Time Frame: baseline and 18 weeks ]A 2-hr OGTT will be performed to assess changes in glucose tolerance and insulin responses to the glucose challenge. Blood samples will be drawn before and after (30, 60, 90, and 120 min) a 75-g glucose ingestion for the determination of plasma glucose and insulin. An estimate of insulin sensitivity by the homeostasis model assessment (HOMA) score will be calculated with the formula: fasting plasma insulin (μU/ml) × glucose (mmol/l)/22.5 (25). Glucose and insulin areas will be determined using Tai's model(26): ½×30×(y0min+2y30min+2y60min+2y90min+y120min), where y represents insulin or glucose values at the different time points.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02869659
|Contact: Charlotte Crottsfirstname.lastname@example.org|
|United States, North Carolina|
|Wake Forest Health Sciences||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Charlotte Crotts 336-713-8503 email@example.com|
|Principal Investigator:||Jingzhong Ding, PhD||Wake Forest University Health Sciences|