Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Change in continuous glucose monitor (CGM) time-in-range
研究概览
简要总结
Despite strong evidence that tight control of blood sugar reduces the risk of diabetes complications, most people with type 1 diabetes do not achieve recommended blood sugar targets. This randomized controlled trial will test whether a very-low- carbohydrate ketogenic diet can effectively and safely improve blood sugar control in adults with type 1 diabetes.
详细描述
A very-low-carbohydrate ketogenic diet (≤50 g carbohydrate/day) could reduce glycemic variability, total daily insulin requirement, and HbA1c in people with type 1 diabetes (T1D). Indeed, several case series and observational studies of using a ketogenic diet (KD) in people with T1D have observed such benefits. However, no randomized controlled trials (RCTs) have evaluated the efficacy of KD for >7 days in people with T1D. In addition, there are serious concerns regarding the safety and tolerability of a KD in patients with T1D, including the potential for an increased risk of hypoglycemia, diabetic ketoacidosis, dyslipidemia, insulin resistance, decreased bone mineral density, and impaired quality of life. This study is a 12-week RCT to evaluate the clinical efficacy, metabolic function, safety, socio-behavioral impact, acceptability and potential for dissemination of an isocaloric KD compared with an American Diabetes Association-recommended control diet in adults with T1D.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤65 years
- •T1D diagnosed >1 year prior to screening
- •HbA1c 7.0%-9.0%
- •Stable insulin delivery method for the past 30 days
- •Ability to read all device instructions and insulin pump settings
- •eGFR ≥60 mL/min/1.73 m2
- •Use of an insulin pump or insulin delivery by multiple daily injections
- •Use of personal CGM for at least 12 weeks and willing to change to Dexcom CGM for the duration of the study, if using a different sensor, to reduce variability in glucose values associated with different CGM products
- •Use of cellular phone with data capability for wireless connectivity to the CGM system.
排除标准
- •Body mass index <20.0 or >34.9 kg/m2
- •Severe gastroparesis or history of bariatric surgery
- •Diabetes-related hospitalization (including for diabetic ketoacidosis or severe hypoglycemia) within 12 months of screening
- •Poorly controlled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg)
- •Taking diabetes medications, other than insulin (particularly SGLT2 inhibitors, which are associated with an increased risk of euglycemic DKA)
- •Structured exercise >210 minutes per week
- •Pregnant, lactating, not using effective birth control if premenopausal, or planning to become pregnant within the 6-month study period
- •Unstable weight (>4% change in the last 2 months)
- •Significant organ system dysfunction (e.g., severe pulmonary, renal, hepatic, or cardiovascular disease)
- •Anemia (Hgb <10 g/dL)
- •Major psychiatric illness
- •Active tobacco use (>8 cigarettes/day) or illegal drug use
- •Regular alcohol consumption (>10 standard drinks per week)
- •Use of medications known to affect the study outcome measures or increase the risk of study procedures that cannot be temporarily discontinued for this study
- •Familial hypercholesterolemia
- •Active eating disorder
- •Dietary restrictions incompatible with a very-low-carbohydrate KD, vegan diet, vegetarian diet, severe lactose intolerance, severe aversion/sensitivity to eggs, fish, nuts, wheat, or soy, and any anaphylactic food allergy
- •Already consuming a low-carbohydrate (<130 g/day) diet
- •Persons who are not able to grant voluntary informed consent
- •Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers an inappropriate candidate for the study.
结局指标
主要结局
Change in continuous glucose monitor (CGM) time-in-range
时间窗: Before and immediately after the dietary intervention
Interstitial glucose percent time in range assessed by using a continuous glucose monitor
Change in skeletal muscle insulin sensitivity
时间窗: Before and immediately after the dietary intervention
Insulin sensitivity will be determined by the hyperinsulinemic-euglycemic clamp procedure
次要结局
- Change in daily insulin requirements(Assessed before, during, and immediately after the dietary intervention)
- Change in 24-hour glucagon concentrations(Before and immediately after the dietary intervention)
- Change in whole-body palmitate turnover(Before and immediately after the dietary intervention)
- Change in plasma lipid profile(Before and immediately after the dietary intervention)
- Change in hepatic de novo lipogenesis(Before and immediately after the dietary intervention)
- Change in 24-hour glucose concentrations(Before and immediately after the dietary intervention)
- Change in fat-free mass(Before and immediately after the dietary intervention)
- Change in intrahepatic triglyceride content(Before and immediately after the dietary intervention)
- Change in de novo cholesterol synthesis(Before and immediately after the dietary intervention)
- Change in fat mass(Before and immediately after the dietary intervention)
- Change in specific adipose tissue volumes(Before and immediately after the dietary intervention)
- Change in plasma hs-CRP(Before and immediately after the dietary intervention)
- Change in plasma PAI-1(Before and immediately after the dietary intervention)
- Change in plasma IL-6(Before and immediately after the dietary intervention)
- Change in plasma TNF-alpha(Before and immediately after the dietary intervention)
- Change in plasma markers of liver function(Before and immediately after the dietary intervention)
- Change in plasma markers of kidney function(Before and immediately after the dietary intervention)
- Change in plasma markers of bone turnover(Before and immediately after the dietary intervention)
- Change in percent time in hypoglycemia(Before and immediately after the dietary intervention)
- Change in percent time in hyperglycemia(Before and immediately after the dietary intervention)
- Level 3 hypoglycemia event rate(During the dietary intervention)
- Diabetic ketoacidosis event rate(During the dietary intervention)
- Change in bone mineral density(Before and immediately after the dietary intervention)
- Change in sociobehavioral factors(Before and immediately after the dietary intervention)
- Knowledge and perceptions of the diet(Immediately after the dietary intervention)
- Adaptations needed to implement the diet at the population level(Immediately after the dietary intervention)
- Change in glycated hemoglobin and albumin(Before, during, and immediately after the dietary intervention)