The Activation of Brown and Beige Fat and Role in Insulin Sensitivity
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Change in beige adipose tissue
研究概览
简要总结
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.
详细描述
The purpose of this study is to determine whether the amount and activity of brown adipose tissue (BAT) and beige adipose can be increased with the use of Mirabegron or Pioglitazone, alone or in combination.
The research procedures will be conducted at the University of Kentucky (UK) Medical Center at the Center for Clinical Translational Sciences research unit (CCTS). Study participants will need to come to the CCTS Unit for approximately 9 visits, as outlined below. Most of these visits will be less than 1 hour, but 3 visit will involve procedures and will vary in time ranging from 4 hour to 8 hours. Thus, a participant's total participation will be approximately 9 visits over the next 12 weeks.
After passing the screening phase, participants will be randomized (like the flipping of coin) at Visit 4 to one of three treatment groups and the participant will stay in their assigned treatment group during their entire participation in the study. The three groups are:
- Group M: Mirabegron 50 mg/day
- Group P: Pioglitazone 30 mg/day
- Group MP: combination Mirabegron 50 mg/day and Pioglitazone 30 mg/day
Fasting requirements: Nothing to eat after 9 pm the night before a specific test or procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Mirabegron
Mirabegron 50 mg/day
干预措施: Mirabegron (Drug)
Pioglitazone
Pioglitazone 30 mg/day
干预措施: Pioglitazone (Drug)
Mirabegron and Pioglitazone
Combination of Mirabegron 50 mg/day and Pioglitazone 30 mg/day
干预措施: Mirabegron and Pioglitazone (Drug)
结局指标
主要结局
Change in beige adipose tissue
时间窗: 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
Change in brown adipose tissue
时间窗: 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
Change in insulin sensitivity
时间窗: 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
次要结局
- Change in body mass index(baseline and after 10 weeks of treatment)
- Change in glucose tolerance(baseline and after 10 weeks of treatment)
研究者
Philip Kern
Principal Investigator
University of Kentucky