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ACTIVE NOT RECRUITING

NCT06998238

Evaluating the Influence of Diet-induced Weight Loss on Fat (Adipose) Tissue's Insulin Sensitivity and Testosterone Synthesis in Women With Overweight or Obesity, Insulin Resistance, and Hyperandrogenemia

Sponsor: University of Missouri-Columbia

View on ClinicalTrials.gov

Summary

The investigators will measure plasma concentrations of the hormones insulin and testosterone as well as measures of insulin sensitivity in women with overweight or obesity who have insulin resistance (IR). Women who meet these criteria that also have elevated total or free testosterone will be eligible to participate in the diet intervention. The dietary intervention is designed to produce a 5% reduction in starting body weight to test whether weight loss will acutely lower fasting insulin and testosterone concentrations.

Official title: The Interplay Between Androgens, Insulin, and Adipose Tissue Metabolism

Key Details

Gender

FEMALE

Age Range

21 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-01-07

Completion Date

2026-04-01

Last Updated

2026-03-17

Healthy Volunteers

Conditions

Overweight and Obesity Hyperandrogenemia Insulin Resistance

Interventions

BEHAVIORAL

Mediterranean-based, carbohydrate restricted, calorie reduced diet

Dietary intervention - calorie reduced (300-500 kcal/day below estimated energy needs), carbohydrate restricted (\<100 grams of available carbohydrates per day), Mediterranean-based (high fat diet with an emphasis on the addition of healthy fats - nuts, avocados, olive oil, increasing whole grains, increasing fruit and vegetables, replacing red meats with fish and poultry, reducing dairy, and reducing added sugars) diet.

Inclusion Criteria: * Women (female sex, premenopausal) * Age 21-45y * Overweight/obesity with BMI ≥25.0 or ≤50.0 kg/m2 * Prediabetic (fasting glucose between 100-125 mg/dL,HbA1c between 5.7-6.4%, blood glucose ≥ 140 mg/dL, but ≤ 200 mg/dL at 2 hours into OGTT) or diabetic with a fasting glucose \<200 mg/dL, stably treated with metformin for 2 months or longer * Alternatively: if not prediabetic as evidenced by abnormal fasting blood glucose or glucose tolerance, evidence of insulin resistance such as fasting insulin value ≥ 10 µU/mL, elevated HOMA-IR or elevated QUICKI may be substituted o Prediabetes and diabetes are associated with insulin resistance and excess body weight. Our study seeks to improve impaired insulin signaling through weight loss from dietary restriction. Therefore, insulin resistance in the presence of normal glucose tolerance may still be improved through this intervention. * Plasma testosterone concentration \<200 ng/dL, as measured at screening visit * Weight stable: No fluctuations in body weight of greater than 4 kg in the last 2 months (see exclusion criteria for undergoing weight loss) * Presence of central (android) obesity as defined by WHR \> 0.8 or waist circumference \> 80 cm * No use or active use of hormonal contraceptives (IUD, oral contraceptive pill, Nexplanon) o Hormonal contraceptives are not expected to alter the outcomes of this study; therefore, their use is not prohibited. However, it is not a requirement that women use hormonal contraception to be part of this study. * Willingness to consume a defined diet (Intervention arm - Weight loss) Exclusion Criteria: * Pregnant or trying to become pregnant * Postmenopausal as testosterone naturally increases with menopause * BMI of \<25.0 or \>50.0 kg/m2 * Use of tobacco, cannabis, or other recreational drug products. o Tobacco and other recreational drugs products are excluded as they known to increase adipose lipolysis. Cannabis products are excluded as they are fat soluble compounds and could alter the adipose gene and protein expression. * Taking medications known to affect adipose tissue metabolism (steroids, niacin) * Use of antiandrogen medications (spironolactone, flutamide, finasteride) within the last 3 months o These medications are designed to lower testosterone concentrations. * Already undergoing weight loss. o As this study is investigating the impact of weight loss, the goal is to obtain samples before and after weight loss (intervention arm) or during weight stability (control arm). * Diagnosis of congenital adrenal hyperplasia, or Cushing syndrome o These conditions are associated with significantly high androgens in need of medical treatment.

Locations (1)

University of Missouri

Columbia, Missouri, United States