Effect of Meal Frequency on Insulin Resistance, Insulin Secretion, and Hepatic Fat Content in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change in Insulin Resistance
研究概览
简要总结
Aims and priorities of the project The purpose of this study is to
- test the effect of frequency of meals (six vs. two meals daily with the same daily caloric restriction of -500 kcal/day) on insulin sensitivity, insulin secretion, and hepatic fat content.
- characterize some of the mechanisms of action of different frequencies of meals (amount of visceral fat, hepatic fat content, serum concentrations of adipokines, gut hormones, oxidation stress markers).
- test the ability of the participants to maintain hypocaloric diet on both regimens when educated and left to prepare their meals alone in comparison with those for whom all meals during the study will be provided.
It will be a randomized, crossover study, where 50 individuals with type 2 diabetes will change in a random order two regimens: six, and two meals a day. Each testing period will take three months.
Glucose and lipid metabolism and its regulation will be thoroughly tested at start, and after each 3-months-period (meal test, hyperinsulinemic isoglycemic clamp, indirect calorimetry, MRI scan of the liver, DXA scan, serum concentration determination of selected adipokines, gut hormones, and oxidation stress markers).
Hypothesis The investigators hypothesize that low plasma insulin levels (as achieved by periods of fasting) will reduce insulin resistance and hepatic lipid content. In contrast, frequent meals (and consequent higher plasma levels of insulin) will predispose to non-alcoholic fatty liver disease and insulin resistance. The investigators further hypothesize that the participants will increase their caloric intake with increased meal frequency (in spite of thorough education) when left to prepare their meals in comparison with those for whom all meals will be provided.
详细描述
Aims and priorities of the project The purpose of this study is to
- test the effect of frequency of meals (six vs. two meals daily with the same daily caloric restriction of -500 kcal/day) on insulin sensitivity, insulin secretion, and hepatic fat content.
- characterize some of the mechanisms of action of different frequencies of meals (amount of visceral fat, hepatic fat content, serum concentrations of adipokines, gut hormones, oxidation stress markers).
- test the ability of the participants to maintain hypocaloric diet on both regimens when educated and left to prepare their meals alone in comparison with those for whom all meals during the study will be provided.
It will be a randomized, crossover study, where 50 individuals with type 2 diabetes will change in a random order two regimens: six, and two meals a day. Each testing period will take three months.
Glucose and lipid metabolism and its regulation will be thoroughly tested at start, and after each 3-months-period (meal test, hyperinsulinemic isoglycemic clamp, indirect calorimetry, MRI scan of the liver, DXA scan, serum concentration determination of selected adipokines, gut hormones, and oxidation stress markers).
Hypothesis The investigators hypothesize that low plasma insulin levels (as achieved by periods of fasting) will reduce insulin resistance and hepatic lipid content. In contrast, frequent meals (and consequent higher plasma levels of insulin) will predispose to non-alcoholic fatty liver disease and insulin resistance. The investigators further hypothesize that the participants will increase their caloric intake with increased meal frequency (in spite of thorough education) when left to prepare their meals in comparison with those for whom all meals will be provided.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes for more than 1 year
- •Treatment of T2D. Oral hypoglycemic agents stable for the last 3 months
- •HbA1c ≥4.2 and ≤10.5% (IFCC)
- •Agek 30-70 years
- •Body Mass Index (kg/m2) between 27 and 50
- •Willingness to follow both different dietary regimens
- •The patient has at least 3 of the symptoms of the metabolic syndrome
排除标准
- •Alcoholism or drug abuse
- •Pregnancy, lactation
- •Nonstable medication for diabetes, hypertension or dyslipidemia in the last 3 months
- •Diagnosis of type 1 diabetes
- •Weight loss or weight gain in the last 3 months (> 5% of the total body weight)
- •Cardiostimulant
结局指标
主要结局
Change in Insulin Resistance
时间窗: Insulin resistance will be measured at weeks 0, 12 and 24. Change from baseline to 12 weeks and from week 12 to week 24 will be assessed.
Insulin Resistance measured by hyperinsulinemic isoglycemic clamp
次要结局
- hepatic fat content(Hepatic fat content will be measured at weeks 0, 12 and 24. Change from baseline to 12 weeks and from week 12 to week 24 will be assessed.)
- Insulin Secretion(Insulin secretion will be measured at weeks 0, 12 and 24. Change from baseline to 12 weeks and from week 12 to week 24 will be assessed.)
- insulin sensitivity(Insulin secretion will be measured at weeks 0, 12 and 24.)
- Fatty acid composition in serum phospholipids(Weeks 0,12 and 24)
- Gastrointestinal peptides(Weeks 0, 12 and 24)
- Oxidative stress markers and AGEs(weeks 0,12 and 24)
研究者
Hana Kahleova
Dr.
Institute for Clinical and Experimental Medicine