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临床试验/NCT02987335
NCT02987335已完成不适用

Metabolic Characteristics of Lean Diabetes in Rural and Semi-urban India and in the United States

Albert Einstein College of Medicine0 个研究点目标入组 100 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
100
主要终点
Rate of Glucose Disposal (RD).

研究概览

简要总结

This purpose of this study is to define the metabolic characteristics of individuals with Lean Diabetes. We aim to determine whether differences in body composition, including any differences in lipid (fat) deposition, exist compared to individuals with either known forms of diabetes (eg, type 1 and type 2), or individuals without diabetes. Diabetes affects the ability of the body to process glucose (sugar). Therefore, we also plan to investigate the ability of the hormone insulin to regulate changes in glucose in these individuals. Developing a greater understanding of the features of this condition could have tremendous therapeutic benefit for these individuals.

详细描述

India has the world's highest prevalence of diabetes, expected to rise to 80 million by 2030. This includes many patients with Lean Diabetes, which is a form of diabetes identified clinically by early onset, high insulin requirements, absence of other pancreatic disease, and low body mass index (typically ≤17 kg/m2) at presentation. Despite its prevalence, Lean Diabetes remains a relatively unknown disease that stirs conflicting opinions regarding its classification, diagnostic criteria, and pathogenesis.

In this study, the investigators will study individuals meeting the criteria for Lean Diabetes, Type 1 diabetes, Type 2 diabetes, and two group of participants without diabetes using a procedure called a "pancreatic clamp" study. During the clamp procedure, glucose (a sugar) and insulin (a hormone produced in the pancreas that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism. Endogenous glucose production (a measure of the body's production of sugar) will also be measured. Participants will also have a fat biopsy, and will be given a mixed meal challenge which is a test that detects hyperglycemia and glucose intolerance.

The overall goal of this study is to define the metabolic characteristics of individuals with Lean Diabetes and to determine which differences exist compared to individuals with other known forms of diabetes or individuals without diabetes.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
19 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 19-45 yr
  • Diabetes duration at least one year (for the diabetes groups)
  • BMI range: 16-22.5 kg/m2 (individuals with lean and type 1 diabetes and non-diabetic controls); 22.5-27 kg/m2 in individuals with type 2 diabetes
  • Negative GAD antibodies
  • Present (>1.0pmol/l) C-peptide response to Sustacal challenge
  • Stable and moderate-to-poor glycemic control (HbA1c greater than 8%)
  • Able and willing to provide informed consent.

排除标准

  • Mentally disabled persons
  • Major psychiatric disorder on medication (excluding successfully treated depression)
  • History of any cancer
  • Alcohol or substance abuse or toxin exposure which could be associated with neuropathy
  • Cushing's syndrome
  • Pregnancy or breast-feeding
  • Untreated or uncontrolled hypertension
  • Any Chronic illness requiring medication
  • History of bleeding disorder or with a prolonged PT or PTT
  • Renal disease
  • Liver impairment
  • Prisoners

研究组 & 干预措施

Lean Diabetes Subjects

N=20 subjects with BMI 16-22.5 kg/m2, with a history of low birth weight and malnutrition documented on at least one occasion. Will undergo pancreatic clamp.

干预措施: Pancreatic Clamp (Drug)

Type 2 Diabetes Mellitus Subjects

N=13 subjects with BMI 22.5-27 kg/m2. Will undergo pancreatic clamp

干预措施: Pancreatic Clamp (Drug)

Type 1 Diabetes Mellitus Subjects

N=15 subjects with BMI 16-22.5 kg/m2. Will undergo pancreatic clamp

干预措施: Pancreatic Clamp (Drug)

结局指标

主要结局

Rate of Glucose Disposal (RD).

时间窗: 240 min to 360 min

Peripheral Insulin Sensitivity (RD) measured by the change in Glucose Rates of Disappearance in each group during the low phase of the pancreatic clamp study.

Endogenous Glucose Production

时间窗: 120 min to 240 min

Measurements of Endogenous glucose production in each group during the low phase of the pancreatic clamp study.

次要结局

  • Insulin Secretion(0 min to 120 min)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meredith Hawkins

Professor of Medicine

Albert Einstein College of Medicine

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