Impact of Meal Insulin Dose Timing on Meal Fat Storage in Patients With Type 1 Diabetes: a Randomized Control Trial - the TiMeD-T1D Project
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Difference in meal fat storage in visceral adipose tissue
研究概览
简要总结
The aim of the proposed study is to investigate the metabolic consequences of varying the timing of meal insulin boluses and skipping boluses altogether in individuals with type 1 diabetes.
The investigator hypothesize that delaying or skipping meal insulin boluses leads to greater ectopic fat storage due to a delayed stimulation of lipoprotein activity and delayed suppression of lipolysis and VLDL-TG secretion.
详细描述
The study will be carried out as a randomized cross-over clinical investigational trial. The investigators will include 10 individuals with type 1 diabetes. The subjects will be invited for four visits in total: one screening visit and three test days separated by a one-week washout period. At the test days, subjects will consume a liquid mixed meal and: 1) take a meal bolus of insulin 20 min before consuming a liquid mixed meal or 2) take a meal bolus of insulin 20 min after the meal or 3) skip the meal bolus of insulin.
The investigators will apply the 18F-FTHA meal fat tracer method to the liquid mixed meal to determine whole-body organ-specific meal fat storage.
The volunteers will arrive fasted (8 hours) at the Department of Nuclear Medicine & PET-Centre at 9.00 a.m. Upon arrival, participants will be placed in a bed and have an arterial catheter placed for arterial blood sampling collected at baseline and during the entire trial day. Approximately one hour after arriving, participants will consume a liquid mixed meal consisting of 400 mL Fresubin Energy Drink and 100 mL heavy cream with the addition of the 18F-FTHA radiotracer. 5 hours after consumption of the liquid mixed meal one static whole-body PET-scan will be performed with a duration of 1 hours. After the PET-scan participants will be provided with a meal. Subsequently, the investigator will make sure the participants is metabolic corrected and then the trial day is ended, and they can go home.
The three test days will be conducted in the same way, except for the timing of insulin bolus administration relative to the meal, which will vary as follows:
- Meal insulin bolus 20 min before consumption of a liquid mixed meal (as recommended)
- Meal insulin bolus 20 min after consumption of a liquid mixed meal
- Skipping the insulin bolus Insulin will be administered subcutaneously, with the dose determined based on the composition of the liquid mixed meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Type 1 diabetes duration > 3 years or c-peptide negative
- •Written and informed consent
排除标准
- •Medicine with an impact on blood glucose or blood pressure
- •Affected screening blood sample as evaluated by the clinical responsible investigator.
- •Alcohol or substance abuse
- •BMI > 35 kg/m2 or < 18.5 kg/m2
- •Participation in other clinical trials involving ionized radiation within the last 6 months
- •Lactose intolerance
- •Doesn't speak and understand Danish.
- •Severe claustrophobia.
- •Commitment to special diets
结局指标
主要结局
Difference in meal fat storage in visceral adipose tissue
时间窗: 18F-FTHA PET scan 300 minutes after consumption of the liquid mixed meal
Difference in meal fat storage (18F-FTHA PET scan) in visceral adipose tissue following a liquid mixed meal and varying the timing or skipping of meal insulin boluses.
次要结局
- Difference in postprandial triglycerides(-20 to 360 minutes after consumption of the mixed meal)
- Meal fat storage in target organs and tissues(300 min after consumption of the mixed meal)
- Postprandial hormonal response and metabolites(-20 to 360 minutes after consumption of the mixed meal)