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
NCT06998238 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2026-03-17
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.
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.
Sponsors & Collaborators
-
University of Missouri-Columbia
lead OTHER
Principal Investigators
-
Elizabeth J Parks, PhD · University of Missouri-Columbia
-
Jean Ricci Goodman, MD · University of Missouri-Columbia
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-07
- Primary Completion
- 2024-10-05
- Completion
- 2026-04-01
Countries
- United States
Study Locations
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