Brown Fat Activation Study

• Status: Completed
• Trial end date: 2019-02-04
• Target enrollment: 0
• Participant gender: All

Summary

This is an open lable, pilot study in which the investigator will research the effect of two FDA approved drugs, Mirabegron and Pioglitazone on fat tissue.

Pioglitazone is drug approved by the FDA for the treatment of diabetes and Mirabegron is a drug that is approved by the FDA for the treatment of overactive bladder. These drugs are not approved by the FDA for the purposes being studied in this research. Therefore, the way in which the investigator intends to use them in this study are considered investigational.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Philip Kern
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Mirabegron; Pioglitazone

Criteria

Inclusion Criteria:

• slightly abnormal blood sugar (A1C between 5.7 and 6.5 or impaired glucose tolerance)

• Metabolic Syndrome features (hypertension, abnormal lipids, abdominal obesity)

• Body Mass Index between 27-45

• Ambulatory

Exclusion Criteria:

• A history of heart disease

• Cancer or a history of cancer within the last 5 years

• Kidney disease

• Currently taking steroids or anticoagulants

• A chronic inflammatory condition such as rheumatoid arthritis or inflammatory bowel disease

• A body mass index (BMI) greater than 45

• Diabetes or the chronic use of any antidiabetic medications

• Uncontrolled blood pressure, urinary retention, overactive thyroid

• Significant swelling in hands, feet, face, arms.

• Currently taking β-blockers

• Daily use of NSAIDS or other anti-inflammatory drugs (eg. corticosteroids)

• Using low-dose aspirin (Participants will need to discontinue use for 7 days prior to the biopsies)

• Antiplatelet medication or blood thinners (examples: Aspirin, warfarin, Effient, Plavix)