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Can a Low-Carb diet tame insulin and testosterone in overweight women?

NCT ID NCT06998238

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

8 people

The number who actually took part.

Started

Jan 2024

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

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

21 to 45 years

Sex

Female participants only

Healthy volunteers

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

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.

Insulin Resistance Obesity obesity disorder Overweight polycystic ovary syndrome Weight Loss

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Missouri

    Columbia, Missouri, 65211, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.