Overweight and ObesityWAISTNCT06998238
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
A study testing Mediterranean-based, carbohydrate restricted, calorie reduced diet in people with Overweight and Obesity and Hyperandrogenemia, run by University of Missouri-Columbia at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 45 years, women only
- Conditions the study is for
- Overweight and Obesity, Hyperandrogenemia, Insulin Resistance
- What is being tested?
- Mediterranean-based, carbohydrate restricted, calorie reduced diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2024to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Interplay Between Androgens, Insulin, and Adipose Tissue Metabolism
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.
Read the detailed description
The investigators will measure the efficacy of a diet-induced weight loss intervention to reduce blood concentrations of the hormone's insulin and testosterone over the course of 2 months in women who have overweight or obesity and evidence of IR. Women meeting the eligibility criteria that have biochemical evidence or clinical manifestations of hyperandrogenemia (HA), or elevated blood androgens - testosterone or free testosterone - will be eligible for the dietary intervention arm of the study. A Mediterranean-based, calorie reduced, carbohydrate restricted diet will be employed to produce a 5% weight loss over the 8 weeks of the intervention. Participants will be provided with a full menu of meals and snacks for 4 of the 8 weeks in the study and will meet with a registered, licensed dietitian routinely for nutrition counseling and to ensure dietary compliance. Those in the dietary intervention will undergo 6 clinical visits at the Clinical and Translational Science's Unit whereas the control group (no dietary intervention or nutrition counseling) will undergo 2 clinical visits. Of the 6 study visits, 4 will include an adipose tissue biopsy and an oral glucose tolerance test. All visits will include DEXA measurement of body composition and collection of fasting blood samples. The control group's 2 study visits will occur at the start and end of the 8-week period and will include all study measurements (i.e., adipose tissue biopsies, oral glucose tolerance tests, DEXA scans, and fasting blood samples). Adipose tissue samples will be cultured and used to assess adipose-level insulin sensitivity. Area under the curve for insulin, glucose, and non-esterified fatty acids (NEFA) will be calculated from the samples collected during the oral glucose tolerance test. Additionally, the fasting HOMA-IR, Matsuda Index, QUICKI value, 2-hour blood glucose concentration, and NEFA suppression will be measured during the oral glucose tolerance test.
- Being tested
- Mediterranean-based, carbohydrate restricted, calorie reduced diet
- Keywords
- Insulin resistance, Hyperandrogenemia, Weight loss, Mediterranean Diet, Women, Overweight or Obesity
- Medical subject headings
- Overweight, Obesity, Insulin Resistance, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean-based, carbohydrate restricted, calorie reduced dietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Dietary intervention | Experimental | Group receiving the study diet and nutrition counseling. Receives: Behavioral: Mediterranean-based, carbohydrate restricted, calorie reduced diet |
| Control | No intervention | Group that performs repeat measures over the span of 8 weeks without any intervention or influence from study team in the interim. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting hormone concentrations.
Fasting insulin (µU/mL) will be measured and compared to baseline values. Samples are sent to an external CLIA-compliant lab (Quest Diagnostics) for analysis.
Measured: Day 0, day 7, day 14, day 28, day 42, and day 56 for the intervention group and day 0 and day 56 for the control group.
Change in fasting hormone concentrations.
Fasting testosterone (ng/dL) will be measured and compared to baseline values. Samples are sent to an external CLIA-compliant lab (Quest Diagnostics) for analysis.
Measured: Day 0, day 7, day 14, day 28, day 42, and day 56 for the intervention group and day 0 and day 56 for the control group.
Change in body weight (kg).
Change from baseline values will be measured using a calibrated, standard, clinical scale.
Measured: Day 0, day 7, day 14, day 28, day 42, and day 56 for the intervention group and day 0 and day 56 for the control group.
Change in fasting blood biochemistries.
Fasting SHBG (nmol/L) will be measured and compared to baseline values. Samples are sent to an external CLIA-compliant lab (Quest Diagnostics) for analysis.
Measured: Day 0, day 7, day 14, day 28, day 42, and day 56 for the intervention group and day 0 and day 56 for the control group.
Secondary outcomes (6)
Change in whole body insulin sensitivity.
Participants will undergo an oral 75-gram glucose tolerance test. Insulin sensitivity will be assessed using HOMA-IR. This insulin sensitivity index is calculated as [(fasting insulin (µU/mL) x fasting glucose (mg/dL))/405].
Measured: Day 0, day 14, day 28, day 56 for the intervention group and day 0 and day 56 for the control group.
Indirect measure of change in adipose insulin sensitivity.
Change will be calculated relative to the fasting value as the percent suppression of free fatty acids in response to the oral glucose tolerance test. Plasma free fatty acids are measured in mmol/L.
Measured: Day 0, day 14, day 28, day 56 for the intervention group and day 0 and day 56 for the control group.
Direct measure of change in adipose insulin sensitivity.
Abdominal subcutaneous adipose tissue (~1 gram) is collected via biopsy. Primary cells are cultured. After differentiation to fully mature adipocytes, the cells are cultured in 1 of 6 media conditions - standard (10 nM insulin, 0 ng/dL testosterone), hyperinsulinemic (100 nM insulin, 0 ng/dL testosterone), hyperinsulinemic and low testosterone (20 ng/dL), hyperinsulinemic and high testosterone (40 ng/dL), standard and low testosterone, standard and high testosterone. Following 10 days of media treatment, adipocyte insulin sensitivity is assessed via a lipolysis assay. This assay measures the release of free fatty acid (mmol/L) from adipocytes in response to cAMP and the subsequent suppression when treated with insulin.
Measured: Day 0, day 14, day 28, day 56 for the intervention group and day 0 and day 56 for the control group.
Change in measures of biochemical hyperandrogenemia.
Fasting free testosterone concentrations (as a percentage (%) of total testosterone) will be estimated. Values will be compared to baseline.
Measured: Day 0, day 7, day 14, day 28, day 42, and day 56 for the intervention group and day 0 and day 56 for the control group.
Change in body composition.
Absolute (kg) and relative (percent of total body mass) fat-free and fat mass are measured using a DEXA at each study visit and compared to baseline values.
Measured: Day 0, day 7, day 14, day 28, day 42, and day 56 for the intervention group and day 0 and day 56 for the control group.
Change in average blood glucose concentrations.
Change in HbA1c % will be measured and compared to baseline values. Samples are sent to an external, CLIA compliant lab (Quest Diagnostics) for analysis.
Measured: Day 0 and day 56 for both the intervention and the control groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start7 Jan 2024
- Primary completion5 Oct 2024
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Jane Parks, University of Missouri-Columbia
- Investigators
- Elizabeth J Parks, PhD, Principal investigator, University of Missouri-ColumbiaJean Ricci Goodman, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998238
- Sponsor's protocol ID
- 2095704
- Acronym
- WAIST
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared upon reasonable request to study's primary investigator, Elizabeth J. Parks, PhD.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interplay Between Androgens, Insulin, and Adipose Tissue Metabolism
- ClinicalTrials.gov ID
- NCT06998238
- Acronym / sponsor ID
- WAIST / 2095704
- Keywords
- Insulin resistance, Hyperandrogenemia, Weight loss, Mediterranean Diet, Women, Overweight or Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 7 Jan 2024 (actual)
- Primary completion
- 5 Oct 2024 (actual)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators will measure the efficacy of a diet-induced weight loss intervention to reduce blood concentrations of the hormone's insulin and testosterone over the course of 2 months in women who have overweight or obesity and evidence of IR. Women meeting the eligibility criteria that have biochemical evidence or clinical manifestations of hyperandrogenemia (HA), or elevated blood androgens - testosterone or free testosterone - will be eligible for the dietary intervention arm of the study. A Mediterranean-based, calorie reduced, carbohydrate restricted diet will be employed to produce a 5% weight loss over the 8 weeks of the intervention. Participants will be provided with a full menu of meals and snacks for 4 of the 8 weeks in the study and will meet with a registered, licensed dietitian routinely for nutrition counseling and to ensure dietary compliance. Those in the dietary intervention will undergo 6 clinical visits at the Clinical and Translational Science's Unit whereas the control group (no dietary intervention or nutrition counseling) will undergo 2 clinical visits. Of the 6 study visits, 4 will include an adipose tissue biopsy and an oral glucose tolerance test. All visits will include DEXA measurement of body composition and collection of fasting blood samples. The control group's 2 study visits will occur at the start and end of the 8-week period and will include all study measurements (i.e., adipose tissue biopsies, oral glucose tolerance tests, DEXA scans, and fasting blood samples). Adipose tissue samples will be cultured and used to assess adipose-level insulin sensitivity. Area under the curve for insulin, glucose, and non-esterified fatty acids (NEFA) will be calculated from the samples collected during the oral glucose tolerance test. Additionally, the fasting HOMA-IR, Matsuda Index, QUICKI value, 2-hour blood glucose concentration, and NEFA suppression will be measured during the oral glucose tolerance test.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention | Experimental | Behavioral: Mediterranean-based, carbohydrate restricted, calorie reduced dietGroup receiving the study diet and nutrition counseling. |
| Control | No intervention | –Group that performs repeat measures over the span of 8 weeks without any intervention or influence from study team in the interim. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean-based, carbohydrate restricted, calorie reduced dietDietary 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. | Behavioural | Dietary intervention |
Primary outcome
Change in fasting hormone concentrations.
Time frame: Day 0, day 7, day 14, day 28, day 42, and day 56 for the intervention group and day 0 and day 56 for the control group.
Fasting insulin (µU/mL) will be measured and compared to baseline values. Samples are sent to an external CLIA-compliant lab (Quest Diagnostics) for analysis.
Change in fasting hormone concentrations.
Time frame: Day 0, day 7, day 14, day 28, day 42, and day 56 for the intervention group and day 0 and day 56 for the control group.
Fasting testosterone (ng/dL) will be measured and compared to baseline values. Samples are sent to an external CLIA-compliant lab (Quest Diagnostics) for analysis.
Change in body weight (kg).
Time frame: Day 0, day 7, day 14, day 28, day 42, and day 56 for the intervention group and day 0 and day 56 for the control group.
Change from baseline values will be measured using a calibrated, standard, clinical scale.
Change in fasting blood biochemistries.
Time frame: Day 0, day 7, day 14, day 28, day 42, and day 56 for the intervention group and day 0 and day 56 for the control group.
Fasting SHBG (nmol/L) will be measured and compared to baseline values. Samples are sent to an external CLIA-compliant lab (Quest Diagnostics) for analysis.
6 secondary outcomes
Change in whole body insulin sensitivity.
Time frame: Day 0, day 14, day 28, day 56 for the intervention group and day 0 and day 56 for the control group.
Indirect measure of change in adipose insulin sensitivity.
Time frame: Day 0, day 14, day 28, day 56 for the intervention group and day 0 and day 56 for the control group.
Direct measure of change in adipose insulin sensitivity.
Time frame: Day 0, day 14, day 28, day 56 for the intervention group and day 0 and day 56 for the control group.
Change in measures of biochemical hyperandrogenemia.
Time frame: Day 0, day 7, day 14, day 28, day 42, and day 56 for the intervention group and day 0 and day 56 for the control group.
Change in body composition.
Time frame: Day 0, day 7, day 14, day 28, day 42, and day 56 for the intervention group and day 0 and day 56 for the control group.
Change in average blood glucose concentrations.
Time frame: Day 0 and day 56 for both the intervention and the control groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: Undecided. Data will be shared upon reasonable request to study's primary investigator, Elizabeth J. Parks, PhD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth J Parks, PhD principal investigator
University of Missouri-Columbia
Jean Ricci Goodman, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean-based, carbohydrate restricted, calorie reduced diet in people with Overweight and Obesity and Hyperandrogenemia, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting hormone concentrations. (time frame: Day 0, day 7, day 14, day 28, day 42, and day 56 for the intervention group and day 0 and day 56 for the control group.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.