Does High-Protein High-Fat Meal Increase Postprandial Glucose Concentrations and Meal-Time Insulin Requirements in Patients With Type 1 Diabetes on Basal-Bolus Insulin Regimen: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Change Postprandial Glucose Concentrations
研究概览
简要总结
The study investigated the effects of fat protein counting (CFP) in addition to carbohydrate (CARB) counting for calculating prandial insulin dosage on blood glucose profile in patients with type 1 diabetes (T1D) on basal-bolus insulin therapy.
详细描述
In this single center, crossover, randomized, controlled study, control meal (SM: standard meal using carbohydrate counting method) and three test meals (HPM: high protein meal using carbohydrate counting method, HPFM-a: high protein-fat meal using carbohydrate counting method and HPFM-b: high protein-fat meal using carbohydrate and fat-protein counting method) were compared on postprandial early (0-120 minutes), late (120-240 minutes) and total (0-240 minutes) glucose response.
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
- None
入排标准
- 年龄范围
- 16 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •had Type1 Diabetes for at least 1 years;
- •use multiple dose (basal-bolus) insulin therapy;
- •use fast-acting insulin analogs (lispro, glulisine, and aspart) and basal insulin analogs (detemir, glargine);
- •daily inslin dose ≥0.5 IU/kg/day.
排除标准
- •had any restrictive food intake disorders (eg celiac disease or food allergy);
- •had any diabetes complications (eg neuropathy, nephropathy or retinopathy);
- •diagnosed for <1 year;
- •were using corticosteroid or any medication that could effect gastric emptying;
- •did exercise or had hypoglycemia or ketoacidosis within 24 hour before the test meals;
- •had overweight or obese (BMI z score: ≥ 1SD and ≥ 2SD respectively);
- •had not on follicular or peri-ovulatory phases of their menstrual cycles (for females).
研究组 & 干预措施
Insulin dose-CARB counting HPM group
HPM (high protein meal), contained 36 g protein,17 g fat, 70 g carbohydrate and 11.5 g fiber, was given to the subjects in breakfast meal (08.30 h) in the hospital. The glycaemic index (GI) of meal was 60.40. The insulin dose for meal was calculated according to the carbohydrate counting (insulin-to-carbohydrate ratio-ICR).Capillary blood glucose values were collected and recorded before (0 min) and every 30 minutes thereafter for 240 minutes.
干预措施: Calculation of insulin dosages for different meals (Other)
Insulin dose-CARB counting HPFM group
HPFM (high protein-high fat meal), contained 36 g protein,30 g fat, 70 g carbohydrate and 11.5 g fiber, was given to the subjects in breakfast meal (08.30 h) in the hospital The glycaemic index (GI) of meal was 60.40. The insulin dose for meal was calculated according to the carbohydrate counting (insulin-to-carbohydrate ratio-ICR).Capillary blood glucose values were collected and recorded before (0 min) and every 30 minutes thereafter for 240 minutes.
干预措施: Calculation of insulin dosages for different meals (Other)
Insulin dose-CARB+FPU counting-HPFM
HPFM (high protein-high fat meal), contained 36 g protein,30 g fat, 70 g carbohydrate and 11.5 g fiber, was given to the subjects in breakfast meal (08.30 h) in the hospital. The glycaemic index (GI) of meal was 60.40. The insulin dose for meal was calculated according to the carbohydrate counting plus fat-protein counting (insulin-to-carbohydrate ratio-ICR and fat-protein unit-FPU).Capillary blood glucose values were collected and recorded before (0 min) and every 30 minutes thereafter for 240 minutes.
干预措施: Calculation of insulin dosages for different meals (Other)
Insulin dose-CARB counting SM group
SM (standart meal), contained 24 g protein,17 g fat, 70 g carbohydrate and 11.5 g fiber, was given to the subjects in breakfast meal (08.30 h) in the hospital. The glycaemic index (GI) of meal was 60.40. The insulin dose for meal was calculated according to the carbohydrate counting (insulin-to-carbohydrate ratio-ICR and fat-protein unit-FPU).Capillary blood glucose values were collected and recorded before (0 min) and every 30 minutes thereafter for 240 minutes.
干预措施: Calculation of insulin dosages for different meals (Other)
结局指标
主要结局
Change Postprandial Glucose Concentrations
时间窗: 0-240 minutes
Change from baseline capillary blood glucose values at 240 min after control and test meals consumption.
次要结局
- Postprandial insulin need([Time Frame: 0-240 minutes])
研究者
Neşe Kaya
Investigator, clinical research
TC Erciyes University