Metabolic Syndrome Clinical Trial
Official title:
The Activation of Brown and Beige Fat and Role in Insulin Sensitivity
Verified date | February 2020 |
Source | University of Kentucky |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | February 4, 2019 |
Est. primary completion date | February 4, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 65 Years |
Eligibility |
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 ß-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) |
Country | Name | City | State |
---|---|---|---|
United States | Center for Clinical and Translational Science | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Philip Kern | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Finlin BS, Memetimin H, Zhu B, Confides AL, Vekaria HJ, El Khouli RH, Johnson ZR, Westgate PM, Chen J, Morris AJ, Sullivan PG, Dupont-Versteegden EE, Kern PA. The ß3-adrenergic receptor agonist mirabegron improves glucose homeostasis in obese humans. J Cl — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in beige adipose tissue | Beige adipose tissue markers will be evaluated at baseline, and after treatment with mirabegron, pioglitazone, or both drugs | baseline and after 10 weeks of treatment | |
Primary | Change in brown adipose tissue | Brown adipose tissue will be evaluated by PET-CT scan at baseline, and after treatment with mirabegron, pioglitazone, or both drugs | baseline and after 10 weeks of treatment | |
Primary | Change in insulin sensitivity | Insulin sensitivity will be assessed at baseline and after treatment with mirabegron, pioglitazone, or both drugs, using a euglycemic clamp | baseline and after 10 weeks of treatment | |
Secondary | Change in body mass index | Body mass index will be assessed at baseline and after treatment with mirabegron, pioglitazone, or both drugs | baseline and after 10 weeks of treatment | |
Secondary | Change in glucose tolerance | Using an oral glucose tolerance test, glucose tolerance will be assessed at baseline and after treatment with mirabegron, pioglitazone, or both drugs | baseline and after 10 weeks of treatment |
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