Heterogeneity Informed Nutrition Therapy for Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- Peak blood glucose following test meal (CGM)
研究概览
简要总结
The hypothesis for this study is that women with different physiologic subtypes of gestational diabetes (GDM) (insulin secretion deficit vs. insulin sensitivity deficit) will differ in their glycemic responses to meals with different portions of dietary macronutrients. Investigators will determine GDM subtype based on glucose and insulin levels taken at multiple time points during an oral glucose tolerance test. Participants will consume two meals with different macronutrient content while wearing a continuous glucose monitor which will allow investigators to assess the glycemic response to the meals.
详细描述
Diabetes mellitus can be classified based on impairments in two different physiologic parameters, insulin secretion and insulin sensitivity. The investigator involved in this trial has previously defined GDM subtypes based on underlying physiology and demonstrated that women with GDM and predominant sensitivity defects have an elevated risk of adverse pregnancy outcomes, while women with predominant secretion defects do not appear to carry the same risk. This supports the idea that not all gestational diabetes is the same. Ideal treatment strategies may differ between GDM subtypes. In this trial, investigators will evaluate the postprandial glycemic response to two test meals with different macronutrient content in different GDM physiologic subtypes. Two test meals with different macronutrient proportions have been designed by research dieticians. Participants will eat test meals at home for breakfast in a randomized order after an overnight fast. Participants will complete food and blood sugar diaries, and will wear a continuous glucose monitor, which will measure postprandial glucose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of gestational diabetes
排除标准
- •Known diabetes mellitus that preceded pregnancy
- •Food allergies to components of the test meals
- •Use of medications known to affect glucose tolerance
- •Have extensive skin changes or diseases making CGM sensor use problematic
- •Demonstrated allergy to CGM adhesive
- •Inability to adhere to the swimming and bathing instructions
- •Plan to have MRI, CT scan, X Ray or diathermy (heat treatment) during the 7-day CGM study period
- •Inability to adhere to Vitamin C guidelines during study period (using more than 500 mg of Vitamin C/day which could interfere with the CGM)
- •Use of medications known to affect glucose tolerance
- •In the opinion of the principal investigator (PI), demonstrate any other factor likely to limit compliance with the protocol
研究组 & 干预措施
Unclassified
Participants who cannot be classified as having abnormal insulin secretion or abnormal insulin sensitivity or who have both abnormal insulin sensitivity and abnormal insulin secretion.
干预措施: Meal B (Other)
Sensitivity defect
Participants defined as having abnormal insulin sensitivity without an absolute defect in insulin secretion.
干预措施: Meal A (Other)
Sensitivity defect
Participants defined as having abnormal insulin sensitivity without an absolute defect in insulin secretion.
干预措施: Meal B (Other)
Secretory defect
Participants defined as having abnormal insulin secretion without a defect in insulin sensitivity.
干预措施: Meal A (Other)
Secretory defect
Participants defined as having abnormal insulin secretion without a defect in insulin sensitivity.
干预措施: Meal B (Other)
Unclassified
Participants who cannot be classified as having abnormal insulin secretion or abnormal insulin sensitivity or who have both abnormal insulin sensitivity and abnormal insulin secretion.
干预措施: Meal A (Other)
结局指标
主要结局
Peak blood glucose following test meal (CGM)
时间窗: 15 mins - 3 hours
Peak postprandial blood glucose after test meal assessed by continuous glucose monitor
次要结局
- Meal satiety(3 hours)
- Meal completion(1 hour)
- Peak blood glucose following lunch on day of test meal (CGM)(15 mins - 3 hours)
- Glucose area under the curve following test meal (CGM)(3 hours)
- One-hour post prandial blood glucose following test meal (SMBG)(1 hour)
- Meal taste(1 hour)
- One-hour post prandial blood glucose following lunch on day of test meal (SMBG)(1 hour)
- Carbohydrate content of lunch after test meal(6 hours)
- Mean blood glucose(24 hours)
- Time in target range(24 hours)
- Total caloric intake on the days of test meals(24 hours)
- Calorie content of lunch after test meal(6 hours)
- Peak blood glucose following dinner on day of test meals (CGM)(15 mins - 3 hours)
- One-hour postprandial blood glucose following dinner on day of test meal (SMBG)(1 hour)
- Carbohydrate content of dinner after test meal(6 hours)
- Calorie content of dinner after test meal(6 hours)
- Time above target range(24 hours)
- Time below target range(24 hours)
研究者
Camille Elise Powe,M.D.
Assistant Professor of Medicine
Massachusetts General Hospital