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Trial record 17 of 396 for:    Recruiting, Not yet recruiting, Available Studies | wake forest

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
Sponsor:
Collaborators:
Medifast, Inc.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief 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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI=30-45.0 kg/m2 OR BMI 27-30, if waist circumference is ≥ 40in in men or ≥ 35in in women
  • Sedentary for past 6 mos (<20 min; 2 d/wk of resistance or aerobic exercise)
  • Normal cognitive function:

Greater than 12 years education:

Caucasian - MOCA ≥ 24 African American/Hispanic/Other- MOCA ≥ 22

12 years or less education: Caucasian- MOCA ≥22 African American/Hispanic/Other- MOCA ≥20

  • No evidence of clinical depression
  • Fasting blood glucose 100-125 mg/dl OR Hemoglobin A1c 5.7% - 6.4%
  • No contraindications for participation in weight loss
  • Able to provide own transportation to study visits and intervention
  • Approved for participation by Medical Director
  • Negative pregnancy test or confirmed post-menopausal/surgically sterile status (Women Only)
  • Not involved in any other research study
  • Willing to provide informed consent

Exclusion Criteria:

  • Weight loss (±5%) in past 6 months
  • Uncontrolled arrhythmias
  • Cancer requiring treatment in past year, except non-melanoma skin cancers
  • Regular smoker (>1 cigarette/day) or heavy drinker (>9 alcoholic drinks/wk) within past year
  • Insulin dependent or uncontrolled diabetes (FBG>126 mg/dl) OR (Hemoglobin A1c 6.5% or greater)
  • Uncontrolled hypertension (BP>160/90 mmHg)
  • Elevated triglyceride (TG>400 mg/dl)
  • Clinically evident liver disease, kidney disease, edema or anemia
  • Past or current ischemic heart disease, uncontrolled angina, heart failure, PAD, stroke, chronic respiratory disease, endocrine or metabolic disease, neurological or hematological disease
  • Regular use growth/steroid hormones, including estrogen replacement, weight loss medications, diabetes medications including insulin and/or blood thinners
  • History of any type of bariatric or weight loss surgery or bilateral oophorectomy requiring long term hormone replacement therapy use

Information from the National Library of Medicine

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


Contacts
Contact: Charlotte Crotts 336-713-8503 chcrotts@wakehealth.edu

Locations
United States, North Carolina
Wake Forest Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Charlotte Crotts    336-713-8503    chcrotts@wakehealth.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
Medifast, Inc.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Jingzhong Ding, PhD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02869659     History of Changes
Other Study ID Numbers: IRB00036970
R01DK103531 ( U.S. NIH Grant/Contract )
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
obesity
pre-diabetes
overweight
lifestyle change
glucose

Additional relevant MeSH terms:
Weight Loss
Prediabetic State
Glucose Intolerance
Body Weight Changes
Body Weight
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia