Phase II Study of Chronic Pancreatitis and the Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Insulin Sensitivity Index for Glycemia at 48 Weeks.
研究概览
简要总结
The purpose of this study is to determine if study drug (Pioglitazone) treatment will improve pre-diabetes (insulin resistance) or ealy diabetes and improve clinical symptoms (pain) or laboratory evidence of chronic pancreatitis.
The goal of the investigators is to gather information from this study to help gain understanding of a potential therapy for chronic pancreatitis.
详细描述
The pancreas is a digestive organ that secretes insulin (and other hormones) into the blood for regulating blood sugar (glucose) and digestive enzymes into the intestine for digesting and absorbing nutrients consumed in meals. Chronic pancreatitis is a progressive clinical disease of the pancreas, associated with swelling (inflammation), scarring (fibrosis) and loss of normal functioning tissue. Patients develop diabetes mellitus (elevated blood sugar), malabsorption of nutrients, weight loss and pain. Presently chronic pancreatitis is considered an irreversible condition because the mechanisms responsible for chronic pancreatitis are poorly understood and no therapy is proven. However, recent studies provide important clues that oral medications (Thiazolidinediones) used to treat diabetes mellitus might improve or reverse features of chronic pancreatitis, including elevated sugar or diabetes, reduced secretion of digestive enzymes, and pancreatic swelling and scarring.
Note: Takeda Pharmaceuticals North America (TPNA) provided pioglitazone and placebo pills with identically appearance until June 28, 2010, approximately the middle of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Insulin resistance or mild diabetes mellitus
- •Symptoms of abdominal pain
- •Xray test showing damage to the pancreas
- •Normal or mildly abnormal stool fat levels
排除标准
- •Mentally disabled patients
- •Women who are planning pregnancy, pregnant or lactating/nursing
- •Chronic pancreatitis is due to other specific conditions
- •Autosomal dominant pancreatitis
- •Classic cystic fibrosis with lung involvement
- •Autoimmune pancreatitis
- •Pancreatic cancer
- •Biliary obstruction (non-pancreatic cause)
- •Abdominal trauma
- •Hypercalcemia
- •Hypertriglyceridemia
- •Surgical resection of the head of the pancreas
- •Alcohol consumption within prior 2 months
- •Specific medical conditions
- •Gastric surgery
- •Celiac sprue
- •Crohns disease
- •Heart failure
- •Kidney failure
- •Cirrhosis or liver disease
- •Osteoporosis
- •Blood clotting disorder
- •Visual problems
- •Low albumin
- •Specific medications *Diabetes drug treatment is allowed except for short-acting insulin, long-acting insule more than 15 units daily, pioglitazone, rosiglitazone, orlistat, acarbose, miglitol or voglibose.
研究组 & 干预措施
Pioglitazone
30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.
干预措施: Pioglitazone (Drug)
sugar pill (placebo)
1 sugar pill (placebo) taken once daily for 48 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Insulin Sensitivity Index for Glycemia at 48 Weeks.
时间窗: 48 weeks
Insulin Sensitivity = Index for Glycemia (ISI gly) = 2 / (\[INSp x GLYp\] + 1). GLYp = Glycemic 0-2 hr area = sum of normalized (based on institutional values) 0 \& 2 hr glucose. INSp = Insulinemic 0-2 hr area = sum of normalized (based on institutional values) 0 \& 2 hr insulin.
Glucose Tolerance at 48 Weeks
时间窗: 48 weeks
1. Normal = normal plasma glucose and normal glucose tolerance (OGTT). 2. Impaired category includes all non-diabetic participants with either a) Impaired fasting glucose = fasting plasma glucose \>110 mg/dl and \<126 mg/dl; or b) Impaired glucose intolerance = 2-hour plasma glucose (OGTT) \>140 mg/dl and \<200 mg/dl. 3. Diabetes = fasting plasma glucose \>126 mg/dl 2-hour (OGTT) plasma glucose \>200 mg/dl.
Glucose Tolerance at 24 Weeks
时间窗: 24 weeks
1. Normal = normal plasma glucose and normal glucose tolerance (OGTT). 2. Impaired category includes all non-diabetic participants with either a) Impaired fasting glucose = fasting plasma glucose \>110 mg/dl and \<126 mg/dl; or b) Impaired glucose intolerance = 2-hour plasma glucose (OGTT) \>140 mg/dl and \<200 mg/dl. 3. Diabetes = fasting plasma glucose \>126 mg/dl 2-hour (OGTT) plasma glucose \>200 mg/dl.
Insulin Sensitivity Index for Glycemia at 24 Weeks
时间窗: 24 weeks
Insulin Sensitivity = Index for Glycemia (ISI gly) = 2 / (\[INSp x GLYp\] + 1). GLYp = Glycemic 0-2 hr area = sum of normalized (based on institutional values) 0 \& 2 hr glucose. INSp = Insulinemic 0-2 hr area = sum of normalized (based on institutional values) 0 \& 2 hr insulin.
次要结局
- Beta-cell Function(24, 48 weeks)
- Hospitalizations(12, 24, 36, 48 and 60 weeks)
- Insulin Resistance at 24 and 48 Weeks(24, 48 weeks)
- Insulin Sensitivity (%S)(24 and 48 weeks)
- Pancreas Ultrasound Appearance(48 weeks)
- Number and Percentage of Participants With Steatorrhea(48 weeks)
- Body Mass Index (BMI)(12, 24, 36, 48 and 60 weeks)
- Quality of Life(24, 48 weeks)
- Pain(12, 24, 36, 48 and 60 weeks)
- Missed Work(12, 24, 36, 48, 60 weeks)
研究者
Matthew DiMagno, MD
Assistant Professor of Internal Medicine
University of Michigan