Health TrialsbyHealthPanel

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

ConditionsPre-diabetesObesity
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age35-65
SponsorPhilip Kern

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Hemoglobin A1C between 5.7 and 6.4

Body mass index between 27 and 45

Disqualifiers

Diabetes

Chronic use of any antidiabetic medications

Any unstable medical condition

Use of steroids or daily use of NSAIDS

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

96 Participants
are divided into 4 treatment groups
Group A: Mirabegron (M)Experimental treatment 1 intervention
Group B: Tadalafil (T)Experimental treatment 1 intervention
Group C: Mirabegron and Tadalafil (MT)Experimental treatment 2 interventions
Group D: Placebo (P)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Oral glucose tolerance test

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

Time frame
Baseline
2

Oral glucose tolerance test

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

Time frame
14 weeks

Secondary outcomes

1

Hemoglobin A1C

Participant hemoglobin A1C will be evaluated at baseline.

Time frame
Baseline
2

Hemoglobin A1C

Participant hemoglobin A1C will be evaluated at 14 weeks.

Time frame
14 weeks

Other outcomes

1

Fat biopsy

Beiging of fat as measured in the lab by histochemistry.

Time frame
Baseline
2

Fat biopsy

Beiging of fat as measured in the lab by histochemistry.

Time frame
14 weeks
3

Muscle biopsy

Fiber type, as measured in the lab by histochemistry.

Time frame
Baseline
4

Muscle biopsy

Fiber type, as measured in the lab by histochemistry.

Time frame
14 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Philip Kern

Lead sponsor

University of Kentucky

Sponsor institution

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

Collaborator

Source ClinicalTrials.gov
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