Growth Hormone Resistance of Beta-cells in Women With Gestational Diabetes Mellitus
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 personal history of gestational diabetes (high blood sugar in pregnancy) at the University of Missouri. The aim of the study is to advance understanding of how growth hormone affects beta-cells and risk factors for developing gestational 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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton, full term pregnancy within the past 5 years
- •Body mass index ≥18.5 kg/m2 and <45.0 kg/m2
- •Group specific inclusion criteria:
- •Gestational Diabetes Group: History of gestational diabetes in the most recent pregnancy
- •Control Group: no history of gestational 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 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
Bettina Mittendorfer
Senior Associate Dean for Research; Professor, Medicine & Nutrition; NextGen Director of Clinical and Translational Sciences Unit
University of Missouri-Columbia