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
- 1
- 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.
研究组 & 干预措施
Ketogenic Diet
The Ketogenic Diet group will consume a very-low carbohydrate diet (<50 g/day) diet. Participants will receive isocaloric packed-out meals for 12 weeks.
干预措施: Ketogenic Diet (Behavioral)
Standard Care
The Standard Care group will consume a diet consistent with the guidelines recommended by the American Diabetes Association that is high in non-starchy vegetables and lean protein sources and low in added sugar. Participants will receive isocaloric packed-out meals for 12 weeks.
干预措施: Standard Diet (Behavioral)
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 24-hour glucose concentrations(Before and immediately after the dietary intervention)
- 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 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)