Valued EpiGenetic Glycemic ImprovEments Through Weight Loss

Plain-language summary

This study evaluates the effects of a weight loss program on epigenetic and blood-sugar (glycemic) levels. It enrolled sedentary adults with obesity (BMI 30-45) whose blood sugar was in the prediabetes range. It was conducted as a study without a phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

Wake Forest University Health Sciences

Intervention

Weight Loss Group, Delayed Weight Loss

Start date

11/1/2016

Estimated completion

12/2/2020

Countries

United States

Related genes

Locations

• Winston-Salem, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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