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Brown Fat Activation Study

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ClinicalTrials.gov Identifier: NCT02919176
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : June 25, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Philip Kern, University of Kentucky

Brief 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.


Condition or disease Intervention/treatment Phase
Obese Metabolic Syndrome Drug: Mirabegron Drug: Pioglitazone Drug: Mirabegron and Pioglitazone Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Activation of Brown and Beige Fat and Role in Insulin Sensitivity
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Mirabegron
Mirabegron 50 mg/day
Drug: Mirabegron
Mirabegron 50 mg/day
Other Name: MYRBETRIQ

Active Comparator: Pioglitazone
Pioglitazone 30 mg/day
Drug: Pioglitazone
Pioglitazone 30 mg/day
Other Name: ACTOS

Experimental: Mirabegron and Pioglitazone
Combination of Mirabegron 50 mg/day and Pioglitazone 30 mg/day
Drug: Mirabegron and Pioglitazone
Mirabegron 50 mg/day and Pioglitazone 30 mg/day
Other Name: MYRBETRIQ and ACTOS




Primary Outcome Measures :
  1. Change in beige adipose tissue [ Time Frame: baseline and after 10 weeks of treatment ]
    Beige adipose tissue markers will be evaluated at baseline, and after treatment with mirabegron, pioglitazone, or both drugs

  2. Change in brown adipose tissue [ Time Frame: baseline and after 10 weeks of treatment ]
    Brown adipose tissue will be evaluated by PET-CT scan at baseline, and after treatment with mirabegron, pioglitazone, or both drugs

  3. Change in insulin sensitivity [ Time Frame: baseline and after 10 weeks of treatment ]
    Insulin sensitivity will be assessed at baseline and after treatment with mirabegron, pioglitazone, or both drugs, using a euglycemic clamp


Secondary Outcome Measures :
  1. Change in body mass index [ Time Frame: baseline and after 10 weeks of treatment ]
    Body mass index will be assessed at baseline and after treatment with mirabegron, pioglitazone, or both drugs

  2. Change in glucose tolerance [ Time Frame: baseline and after 10 weeks of treatment ]
    Using an oral glucose tolerance test, glucose tolerance will be assessed at baseline and after treatment with mirabegron, pioglitazone, or both drugs



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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919176


Contacts
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Contact: Philip Kern, MD 8593235821 pake222@uky.edu
Contact: Zachary Johnson 8592180485 zrjo223@uky.edu

Locations
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United States, Kentucky
Center for Clinical and Translational Science Recruiting
Lexington, Kentucky, United States, 40536
Contact: Zachary Johnson       zrjo223@uky.edu   
Contact: Terri Spear       terri.spear@uky.edu   
Principal Investigator: Philip Kern, MD         
Sponsors and Collaborators
Philip Kern
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Philip Kern, MD University of Kentucky

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Philip Kern, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT02919176     History of Changes
Other Study ID Numbers: 16-0642-F1V
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pioglitazone
Mirabegron
Hypoglycemic Agents
Physiological Effects of Drugs
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents