Role of Nutrient Transit and Incretin Hormones in Hyperinsulinemic Hypoglycemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Steady state plasma glucose (SSPG) as a measure of insulin sensitivity
研究概览
简要总结
Severe hypoglycemia (low blood sugar)after gastric bypass surgery is an increasingly recognized condition, characterized by symptoms of hypoglycemia after eating and inappropriately elevated insulin concentrations that occur at the time of hypoglycemia. Severe hypoglycemia can be dangerous and debilitating and can also impact cognitive function. At the moment no medical therapies have been developed for this disorder. Determining why some but not other patients develop this condition would allow for improved prediction, prevention, and treatment approaches. The purpose of the study is to understand the physiological changes observed in those patients who undergo gastric bypass and develop symptomatic hypoglycemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female patients 18-70 years of age
- •Post-bariatric surgery more than 6 months prior to signing the informed consent (not required for non-surgical controls)
- •Documented history of hyperinsulinemic hypoglycemia (not required for post-bariatric and non-surgical controls)
排除标准
- •Patients currently using sulfonylureas or other medications that may interfere with glucose metabolism within 5 half-lives of drug.
- •Participation in any clinical investigation within 4 weeks prior to dosing
- •History of or current insulinoma
- •Active infection or significant acute illness within 2 weeks prior to dosing
- •Female patients who are pregnant or lactating
- •Women of childbearing potential and not utilizing effective contraceptive methods
- •Inadequate end organ function as defined by: Serum creatinine >2.0 mg/dL, alanine transaminase (ALT) and aspartate aminotransferase (AST) > 2 x Upper Normal Limit
- •Allergy to test meal or medications used in the study
研究组 & 干预措施
Remote Phase: Post-Bariatric Hypoglycemia Patients
Participants will wear continuous glucose monitor (CGM) in a blinded manner (cannot see data output) for 20 days followed by in an unblinded manner (can see data output) for 20 days.
干预措施: Use of Continuous Glucose Monitor (CGM) (Behavioral)
Remote Phase: Post-Bariatric Hypoglycemia Patients
Participants will wear continuous glucose monitor (CGM) in a blinded manner (cannot see data output) for 20 days followed by in an unblinded manner (can see data output) for 20 days.
干预措施: Use of "Cardea Solo" monitoring (Other)
In-Clinic Phase: Post-Bariatric Hypoglycemia Patients
Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions. This group will also wear CGM during a portion of the metabolic tests. This may include participants from the Remote Phase or newly enrolled participants.
In-Clinic Phase: Surgical Controls
Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions.
In-Clinic Phase: Nonsurgical Controls
Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions.
In-Clinic Phase: Post-Bariatric Hypoglycemia Patients with indwelling gastrostomy tube
Participants will undergo standardized mixed meal tolerance tests via oral, gastrostomy tube, and concomitant oral + gastrostomy tube routes of delivery with metabolic parameters assessed.
结局指标
主要结局
Steady state plasma glucose (SSPG) as a measure of insulin sensitivity
时间窗: Baseline 4-hour SSPG
This endpoint applies to the In-Clinic Phase cohorts: Post-Bariatric Hypoglycemia, Surgical Controls, Non-Surgical Controls. This is a one day in-person appointment lasting approximately 6 hours.
Rate of gastric emptying
时间窗: Baseline 4-hour scintigraphy procedure
This endpoint applies to the In-Clinic Phase cohorts: Post-Bariatric Hypoglycemia, Surgical Controls, Non-Surgical Controls. This is an in-person appointment lasting approximately 5 hours.
Concentration of Glucagon-Like peptide 1 secretion augmentation of insulin secretion rate
时间窗: Baseline 4-hour graded-glucose infusion
This endpoint applies to the In-Clinic Phase cohorts: Post-Bariatric Hypoglycemia, Surgical Controls, Non-Surgical Controls. The blood collected from the SSPG will be stored and analyzed for the concentration of GLP-1 at multiple timepoints.
Rate of clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL)
时间窗: 40 days
This endpoint applies to Remote Phase participants
Rate of arrhythmia during hypoglycemia
时间窗: 10 days
This endpoint applies to Remote Phase participants
Percent time in clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL)
时间窗: 40 days
This endpoint applies to Remote Phase participants
次要结局
未报告次要终点
研究者
Tracey McLaughlin
Professor of Medicine, Endocrinology
Stanford University