Valued EpiGenetic Glycemic ImprovEments Through Weight Loss

Completed · Not applicable

Conditions studied: Obesity, Pre-diabetes

In brief

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.

Key facts

Study ID

NCT02869659

Run by

Wake Forest University Health Sciences

People needed

138

Starts

2016-11-01

Expected to finish

2020-12-02

Last updated by the study team

2020-12-31

Who can join

Age: 40 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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
• 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

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

Where it is running

• Wake Forest Health Sciences — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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