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Insulin ResistancePhase 2NCT00123110

Insulin Resistance and Testosterone in Women

A Phase 2 study testing metformin and leuprolide injection in people with Insulin Resistance and Postmenopause, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research study is to determine if a relationship between insulin resistance (IR) and testosterone (T) exists in women who have already gone through menopause. Read more about this study

Who is it for?
Ages 50 to 79 years, women onlyHealthy volunteers can take part
Conditions the study is for
Insulin Resistance, Postmenopause
What is being tested?
metformin and leuprolide injection
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
35 participants
Where
1 siteUnited States
Study dates
Jul 2005to Dec 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 50 to 79 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Postmenopausal women aged 50-79 years with absence of menses for 12 months; for women 50-54 years, Follicle stimulating hormone>30 U/mL to confirm postmenopausal status
  • At least one intact ovary
  • Free testosterone and fasting insulin levels within required study parameters
  • Willing to comply with all study-related procedures
  • Capable of giving informed consent

Who cannot join

  • History of cancer requiring treatment within the past 5 years (exceptions may be made by investigator)
  • Hospitalization for treatment of vascular disease in the past 6 months
  • Uncontrolled hypertension
  • Hospitalization for chronic obstructive pulmonary disease or asthma in the past 3 months
  • Use of continuous oxygen at home
  • Surgery in the last 30 days
Show all 23Show fewer
  • Positive for HIV
  • Abnormal blood tests (hemoglobin, fasting triglycerides, fasting glucose, creatinine, liver function)
  • History of diabetes mellitus or use of any anti-hyperglycemic medication in the past 3 months
  • Disease associated with disordered glucose metabolism (Cushing's disease, acromegaly, pheochromocytoma not surgically cured, chronic pancreatitis)
  • History of chronic renal insufficiency
  • Intravenous (IV) contrast studies with iodinated materials planned for the 12 week intervention period that cannot be postponed according to the participant's primary care provider
  • Acute or chronic metabolic acidosis
  • History of liver disease
  • Congestive heart failure
  • History of androgen-secreting tumors
  • Hormone replacement therapy or antiandrogen use in past 6 months
  • Use of dehydroepiandosterone (DHEA) or other androgen-containing products in past 6 months
  • Corticosteroid use, other than topical, ophthalmic, intraarticular, and inhaled preparations, in past 3 months
  • Undiagnosed current vaginal bleeding
  • Excessive alcohol intake, either acute or chronic; current illicit substance abuse
  • Participation in an investigational drug study within 6 weeks prior to screening visit
  • Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the patient's safety or successful participation in the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania Clinical and Translational Research Center

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Insulin Resistance and Testosterone in Non-Diabetic Postmenopausal Women

The purpose of this research study is to determine if a relationship between insulin resistance (IR) and testosterone (T) exists in women who have already gone through menopause.

Read the detailed description

This study tests the central hypothesis that insulin resistance (IR) increases androgen (male sex hormone) production in postmenopausal women. Participation will include five visits, each lasting on average 2.5 hours, over a period of 13-20 weeks.

At the screening visit, the participant's medical history, current use of medications and dietary supplements, and social habits will be recorded. This information will be reviewed on each subsequent visit; participants are asked to maintain their current diet and physical activity level throughout the study.

A brief physical exam will be performed, and blood will be drawn.

At the 2nd (baseline) visit, patients will undergo a euglycemic-hyperinsulinemic clamp (a procedure to measure insulin sensitivity by continuous intravenous infusion of insulin, and variable infusion of glucose). Blood samples will be drawn throughout the procedure. At completion, the insulin infusion will be stopped, participants will be fed, and the glucose infusion continued for at least 15 minutes to ensure stability of the blood glucose concentration. After the procedure, participants will be randomized to receive either metformin plus leuprolide placebo, leuprolide plus metformin placebo, or metformin placebo plus leuprolide placebo. The leuprolide or leuprolide placebo will be administered as an injection by a nurse. The metformin or metformin placebo will be dispensed to the participant in the form of pills, with instructions for titrating the dose. Participants will be contacted by telephone once weekly during the titration period to assess drug tolerability and adverse events (AEs). Participants will be maintained at their maximum tolerated dose for the duration of the study intervention period.

Participants will return every 4 weeks for follow-up. Blood will be drawn, the nurse will administer the leuprolide or leuprolide placebo injection, and metformin or metformin placebo will be dispensed. At the final visit (week 12), participants will undergo a brief physical exam, and will then undergo a final euglycemic-hyperinsulinemic clamp.

Being tested
metformin, leuprolide injection, placebo pill, placebo injection
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • metforminDrug

    Also called Glucophage

    Initiated on 500 mg daily and titrated up to 1000 mg twice a day during the first four weeks, remaining at that dose until 12 weeks

  • leuprolide injectionDrug

    Also called Lupron

    3.75 mg injection every 4 weeks (e.g. at baseline, 4, and 8 weeks)

  • placebo pillDrug

    matching pill twice a day for 12 weeks

  • placebo injectionDrug

    matching injection every 4 weeks (e.g. baseline, 4, and 8 weeks)

Study groups in NCT00123110
Study groupRoleWhat they receive
1Experimentalmetformin pill plus placebo injection
Receives: Drug: metformin; Drug: placebo injection
2Experimentalleuprolide injection plus placebo pill
Receives: Drug: leuprolide injection; Drug: placebo pill
3Placebo comparatorplacebo pill plus placebo injection
Receives: Drug: placebo pill; Drug: placebo injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change in Free Testosterone (T)

    Percent change in free T by equilibrium dialysis between baseline and 12 weeks

    Measured: Baseline to 12 weeks

  2. Change in Insulin Sensitivity

    Change in insulin sensitivity (mg/kg/min) calculated from hyperinsulinemic euglycemic clamp

    Measured: baseline and 12 weeks

Secondary outcomes (7)

  1. Percent Change in Luteinizing Hormone (LH) From Baseline

    Measured: baseline and 12 weeks

  2. Percent Change in Homeostasis Model Assessment Index of Insulin Resistance (HOMA-IR)

    Insulin resistance calculated from homeostasis model assessment of insulin resistance (HOMA-IR) equation: fasting insulin x fasting glucose / 405. Higher values indicate more insulin resistance.

    Measured: baseline and 12 weeks

  3. Percent Change in Low Density Lipoprotein (LDL)

    Measured: baseline and 12 weeks

  4. Percent Change in Systolic Blood Pressure

    Measured: baseline and 12 weeks

  5. Free T and IR in Women in Whom Metabolic Syndrome is Present vs. Absent

    Measured: baseline and 12 weeks

  6. Dehydroepiandrosterone Sulfate (DHEA-S)

    Measured: baseline and 12 weeks

  7. Body Mass Index (BMI)

    Measured: baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00123110
Sponsor's protocol ID
AG0031
Other IDs
K23AG019161, K23AG1916101A1, 5P30DK019525
Status last verified
May 2019
First submitted
19 Jul 2005
Last updated
23 May 2019
Data monitoring committee
No
Individual data sharing
No

Publications

  • Ford ES, Giles WH, Dietz WH. Prevalence of the metabolic syndrome among US adults: findings from the third National Health and Nutrition Examination Survey. JAMA. 2002 Jan 16;287(3):356-9. doi: 10.1001/jama.287.3.356.

    PubMed 11790215

  • Golden SH, Ding J, Szklo M, Schmidt MI, Duncan BB, Dobs A. Glucose and insulin components of the metabolic syndrome are associated with hyperandrogenism in postmenopausal women: the atherosclerosis risk in communities study. Am J Epidemiol. 2004 Sep 15;160(6):540-8. doi: 10.1093/aje/kwh250.

    PubMed 15353414

  • Larsson H, Ahren B. Androgen activity as a risk factor for impaired glucose tolerance in postmenopausal women. Diabetes Care. 1996 Dec;19(12):1399-403. doi: 10.2337/diacare.19.12.1399.

    PubMed 8941471

  • Oh JY, Barrett-Connor E, Wedick NM, Wingard DL; Rancho Bernardo Study. Endogenous sex hormones and the development of type 2 diabetes in older men and women: the Rancho Bernardo study. Diabetes Care. 2002 Jan;25(1):55-60. doi: 10.2337/diacare.25.1.55.

    PubMed 11772901

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing metformin and leuprolide injection in people with Insulin Resistance and Postmenopause, run by University of Pennsylvania 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 5 inclusion and 23 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: finished, as of the sponsor's last update on 23 May 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Change in Free Testosterone (T) (time frame: Baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00123110, which also lists 4 linked publications.

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 23 May 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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