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临床试验/NCT06571500
NCT06571500招募中不适用

Growth Hormone Resistance of Beta-cells in People With a Family History of Type 2 Diabetes

University of Missouri-Columbia2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Beta-cell function

研究概览

简要总结

The purpose of the research study is to better understand how beta-cells (cells in the pancreas that make insulin and help regulate blood sugar) respond to growth hormone in people with a family history of type 2 diabetes at the University of Missouri. Our aim is to advance understanding of how growth hormone affects beta-cells and risk factors for developing type 2 diabetes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18 to 59 years old
  • body mass index ≥30.0 kg/m2 and <45.0 kg/m2
  • Additional, group-specific inclusion criteria:
  • Family history of type 2 diabetes: first degree relative with type 2 diabetes
  • Control group: no family history of type 2 diabetes

排除标准

  • Pregnant, planning to become pregnant during the study, or breastfeeding
  • Current diagnosis or history of type 1 or type 2 diabetes
  • Use of medications that can impact the study outcomes (e.g., GLP-1 receptor agonists)
  • History of bariatric surgery
  • Known, uncontrolled hypothyroidism
  • History of intracranial hypertension, including papilledema, or a condition that increases the risk of developing intracranial hypertension, such as Turner Syndrome, Prader-Willi Syndrome, or renal impairment
  • Current cancer or cancer that has been in remission less than 5 years
  • First degree relative with type 1 diabetes diagnosis
  • Evidence of significant anemia or significant end organ dysfunction (e.g., liver, kidney, heart disease)
  • Alcohol use disorder, use of controlled substances, or smoking >2 cigarettes per day
  • Greater than 3% weight loss within three months of screening or engaged in regular (≥3 days per week), continuous moderate- or high-intensity exercise of ≥30 min duration
  • Mentally disabled persons, prisoners, and persons with inability to grant voluntary informed consent

结局指标

主要结局

Beta-cell function

时间窗: 15, 30, 60, 120, 240, and 360 min and 7 days after rhGH administration

Insulin secretion rate in relationship to plasma glucose

次要结局

未报告次要终点

研究者

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

Bettina Mittendorfer

Senior Associate Dean for Research; Professor, Medicine & Nutrition; NextGen Director of Clinical and Translational Sciences Unit

University of Missouri-Columbia

研究点 (2)

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