NCT02869659

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2020

Completed
Last Updated

December 31, 2020

Status Verified

December 1, 2020

Enrollment Period

3.7 years

First QC Date

July 25, 2016

Last Update Submit

December 28, 2020

Conditions

ObesityPre-diabetes

Keywords

obesitypre-diabetesoverweightlifestyle changeglucose

Outcome Measures

Primary Outcomes (1)

  • Chang in Epigengene score (and related individual transcriptional and methylation measures)

    The eigengene score is defined as the first principal component of a transcriptional network.

    baseline and 18 weeks

Secondary Outcomes (2)

  • change in glucose tolerance

    baseline and 18 weeks

  • change in homeostatic model assessment (HOMA) estimates of insulin resistance

    baseline and 18 weeks

Study Arms (2)

Control/Delayed Weight Loss Group

ACTIVE COMPARATOR

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

Weight Loss Group

EXPERIMENTAL

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

Interventions

Weight Loss GroupBEHAVIORAL

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

Weight Loss Group
Delayed Weight LossBEHAVIORAL

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

Control/Delayed Weight Loss Group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

  • Mishra SP, Wang B, Jain S, Ding J, Rejeski J, Furdui CM, Kitzman DW, Taraphder S, Brechot C, Kumar A, Yadav H. A mechanism by which gut microbiota elevates permeability and inflammation in obese/diabetic mice and human gut. Gut. 2023 Oct;72(10):1848-1865. doi: 10.1136/gutjnl-2022-327365. Epub 2023 Mar 22.

    PMID: 36948576DERIVED

MeSH Terms

Conditions

ObesityGlucose IntoleranceOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperglycemiaGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Jingzhong Ding, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2016

First Posted

August 17, 2016

Study Start

November 1, 2016

Primary Completion

July 29, 2020

Study Completion

December 2, 2020

Last Updated

December 31, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)