Type 1 Diabetes Management Using a Very Low Carbohydrate Versus Standard Diet
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Hemoglobin A1C change
研究概览
简要总结
Despite major technological advances, management of type one diabetes mellitus (T1D) remains suboptimal, putting millions of people at risk for immediate and long-term complications. After meals, a mismatch between carbohydrate absorption rate and insulin action typically leads to alternating periods of hyper- and hypoglycemia. A conceptually promising approach to control both problems is dietary carbohydrate restriction to reduce postprandial blood glucose changes and insulin needs. In a prior survey study, the investigators documented exceptional glycemic control (HbA1c 5.67%) and low acute complication rates among 316 children and adults with T1D consuming a very-low-carbohydrate diet.
To test the feasibility of this approach, the investigators will conduct a randomized-controlled feeding study involving 32 adults and adolescents with T1D. Participants will be randomized to receive a very low carbohydrate vs. standard carbohydrate diet. Participants will be in the study for 12 weeks and receive all their meals by meal delivery.They will share continuous glucose monitoring data with the study team and be in close communication to adjust insulin doses as needed. All participants will have a screening visit, an individual or group education session, and 3 study visits to evaluate diabetes control and metabolic health. Some of these visits will have a fasting blood draw. Two of the visits will also comprise additional metabolic studies to assess glucagon response and brain function during hypoglycemia by magnetic resonance imaging (MRI). Participants will have IV catheters placed and receive IV insulin to drop blood glucose levels to 50 mg/dl for up to 30 minutes. The primary outcome will be HbA1c change from baseline. Secondary outcomes include detailed measures of glycemic variability, metabolic health, and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females with T1D for at least 1 year
- •Age 18 to 40 years
- •Tanner stage ≥ IV
- •BMI 18.5-35 kg/m2
- •Stable glycemic control (HbA1c 6.5-9%)
- •Use of a continuous glucose monitor (CGM)
- •Use of an insulin pump
- •Attendance of at least 1 diabetes care visit over the past 12 months (including virtual)
排除标准
- •Ketoacidosis or severe hypoglycemia with seizure or coma in the past 6 months
- •Dietary restrictions or intolerances that are incompatible with the planned food deliveries, e.g. celiac disease, gastroparesis, certain food allergies
- •Following a weight-loss or otherwise restrictive diet
- •Vigorous exercise >2 hours on >3 days a week
- •History of an eating disorder or at risk for eating disorder, assessed by the Eating Disorders Diagnostic Scale (EDDS)
- •Major medical illness or use of medications other than insulin and metformin that could interfere with metabolic or glycemic variables
- •Significant psychiatric illness
- •Smoking, use of recreational drugs, or excessive alcohol consumption
- •Pregnancy or breastfeeding
- •For participants who undergo MRI:
- •Standard MRI exclusion criteria
- •Irregular menses
- •Use of psychotropic medication other than SSRIs or other mild antidepressant or anxiety medications (unless these medications are safe to be held for several days to allow for the acquisition of MRI data)
结局指标
主要结局
Hemoglobin A1C change
时间窗: 12 weeks - baseline
HbA1C change from baseline at 12 weeks will be compared between the 2 interventions
次要结局
- percent time spent in hyperglycemia(week 0 and 12)
- blood glucose average(week 0 and 12)
- total daily insulin dose(week 0 and 12)
- percent time spent below the glycemic target of 70 mg/dl(week 0 and 12)
- percent time spent in the glycemic target range of 70-140 mg/dl(week 0 and 12)
- fasting low density lipoprotein cholesterol(week 0 and 12)
- Self-reported quality of life assessed per self-report by The Problem Areas in Diabetes Scale (PAID)(week 0, 6, and 12)
- Becks Depression Inventory II (BDI II) less suicidality(week 0, 6, and 12)
- Yale Food Addiction Scale 2.0 (YFAS 2.0)(week 0, 6, and 12)
- percent time in hypoglycemia below 54 mg/dl(week 0 and 12)
- percent time spent above the glycemic target of 140 mg/dl(week 0 and 12)
- blood glucose standard deviation(week 0 and 12)
- Mean Amplitude of Glycemic Excursions (MAGE), a measure for postprandial glycemic variability(week 0 and 12)
- fasting high density lipoprotein cholesterol(week 0 and 12)
- fasting beta hydroxybutyrate(weeks 0, 1, 2, 4, 6, 9, 12)
- Glycemic Variability Index, a measure for glycemic variability normalized to mean blood glucose level(week 0 and 12)
- fasting total cholesterol(week 0 and 12)
- fasting triglycerides(week 0 and 12)
- fasting high-sensitivity c-reactive protein(week 0 and 12)
- Highly Processed Food Withdrawal Scale (ProWS)(Baseline, daily on days 1-7, then weekly; primary focus on change from baseline to day 7)
研究者
Belinda Lennerz
Principal Investigator
Boston Children's Hospital