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NCT Number: NCT05051436

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

The investigator hypothesizes that treatment with the ß3 agonist mirabegron results in improved glucose metabolism, including a reversal of prediabetes in obese, insulin-resistant human research participants, and this is further improved by combination therapy with tadalafil. The investigator will comprehensively analyze glucose homeostasis in prediabetic patients treated for 14 weeks with mirabegron, tadalafil or both drugs as compared to a placebo.

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Key information

Conditions

Pre-diabetes Body Weight Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location status: Recruiting

Location contact

Philip Kern, M.D.

PRINCIPAL_INVESTIGATOR

Zach Leicht

CONTACT

[email protected]

859-218-1397

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hemoglobin A1C between 5.7 and 6.4
  • Body mass index between 27 and 45

Exclusion criteria

  • Diabetes
  • Chronic use of any antidiabetic medications
  • Any unstable medical condition
  • Use of steroids or daily use of NSAIDS
  • History of chronic inflammatory conditions
  • Use of anticoagulants
  • Contraindications to the use of mirabegron or tadalafil
  • Any condition deemed risky by the study physician

Treatment and study plan

Mirabegron 50 MG

Drug

Mirabegron 50 mg/day will be administered for 14 weeks.

Tadalafil 10 MG

Drug

Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.

Placebo

Drug

Placebo will be administered for 14 weeks after baseline procedures.

Primary outcomes

  1. Oral glucose tolerance test

    Time frame: Baseline

    Participants will complete a standard oral glucose tolerance test using 75 g of glucose at baseline and blood glucose will be measured.

  2. Oral glucose tolerance test

    Time frame: 14 weeks

    Participants will complete a standard oral glucose tolerance test using 75 g of glucose at 14 weeks and blood glucose will be measured.

Secondary outcomes

  1. Hemoglobin A1C

    Time frame: Baseline

    Participant hemoglobin A1C will be evaluated at baseline.

  2. Hemoglobin A1C

    Time frame: 14 weeks

    Participant hemoglobin A1C will be evaluated at 14 weeks.

Other outcomes

  1. Fat biopsy

    Time frame: Baseline

    Beiging of fat as measured in the lab by histochemistry.

  2. Fat biopsy

    Time frame: 14 weeks

    Beiging of fat as measured in the lab by histochemistry.

  3. Muscle biopsy

    Time frame: Baseline

    Fiber type, as measured in the lab by histochemistry.

  4. Muscle biopsy

    Time frame: 14 weeks

    Fiber type, as measured in the lab by histochemistry.

Study contacts

Contact information is provided by the study sponsor or research team.

Philip Kern, M.D.

CONTACT

[email protected]

859-218-1394

Zach Leicht

CONTACT

[email protected]

859-218-1397

Sponsors and collaborators

Lead sponsor

Philip Kern

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2021
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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