Can a Low-Carb diet tame insulin and testosterone in overweight women?
NCT ID NCT06998238
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether a Mediterranean-style low-carb diet that reduces calories can lower insulin and testosterone levels in overweight or obese women with insulin resistance. Eight premenopausal women aged 21-45 will follow the diet to lose about 5% of their body weight. Researchers will measure changes in fasting hormones and insulin sensitivity to understand how weight loss affects these factors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Mediterranean-based, carbohydrate-restricted, calorie-reduced diet
- What this could lead to
- If successful, this study could clarify how weight loss affects insulin and testosterone levels in women with insulin resistance.
- What could go wrong
- This is a very small early-stage study with only 8 participants, so results may not apply to the broader population.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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8 people
The number who actually took part.
- Started
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Jan 2024
- Expected to finish
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Apr 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Missouri
Columbia, Missouri, 65211, United States
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