Effect of Meal Frequency and Timing on Glycemic Control, Daily Insulin Dose Requirements and Clock Gene Expression in Uncontrolled Type 2 Diabetic Patients
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Type 2 Diabetes
- 发起方
- Tel Aviv University
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Insulin Dose
- 状态
- 已完成
- 最后更新
- 7年前
概览
简要总结
This study is undertaken to explore in patients with uncontrolled T2D treated with insulin, whether a diet with large breakfast and lunch with small dinner (Bdiet) will enhance CG expression and will be more effective for weight loss and for achieving glycemic control and reduction of total daily insulin dose (first end point), compared to an isocaloric diet with 6 small meals distributed evenly along the day
详细描述
Obese patients with type 2 diabetes (T2D) and insulin resistance (IR), often require sequential increments of total daily insulin dose (TDID). This causes weight gain, worsens IR, leading to further increase of TDID and persistent hyperglycemia. In these patients, weight loss (WL) and reduction of IR are mandatory in order to achieve glucose control with less TDID. Impaired clock gene (CG) expression is linked to obesity and IR in T2D and it was shown in animals and T2D patients treated with oral anti-hyperglycemic drugs, that WL diet with restricted meal timing to specific hours, restored CG expression and was more effective for WL and for reduction of hyperglycemia compared to isocaloric WL diet, (commonly recommended for T2D), consisting of small meals randomly distributed along the day. The investigators hypothesized that in patients with uncontrolled T2D treated with insulin, a diet with large breakfast and lunch with small dinner (Bdiet) will enhance CG expression and will be more effective for WL and for achieving glycemic control and reduction of TDID, compared to an isocaloric diet with 6 small meals distributed evenly along the day (6Mdiet). This will be a randomized parallel, open label clinical study. Thirty overweight and obese insulin-treated T2D patients with HbA1c\>7.5% will be assigned to 12 weeks of 2 isocaloric diets: either Bdiet or 6Mdiet. HbA1c and CG mRNA expression in white blood cells and overall daily glycemia measured during 14 days, will be assessed before diet, after 14 days and at the end of the diet intervention. The TDID (first end point ) will be adjusted by physician, according to the results of self-monitoring of blood glucose on 3 consecutive days at baseline and before each of the visits.
研究者
入排标准
入选标准
- •T2D patients with stable insulin treatment for at least 3 month preceding the study.
- •HgA1c \>7.5 %.
- •Age \> 30 years.
- •BMI: 27-34 kg/m
- •Treatment with antidiabetic drugs (i.e. metformin, DPP4 inhibitors, glinides) and GLP-1 analogs.
- •Anti-hypertensive treatment will be allowed.
- •Lipid-lowering medication.
- •Exclusion Criteria
- •Type 1 diabetes.
- •Major illnesses (liver, heart, kidney, infectious, neurological, psychiatric, immunological, active malignancy).
排除标准
- 未提供
结局指标
主要结局
Insulin Dose
时间窗: Baseline, 2 week and at 12 weeks
The effects of two diets (Bdiet and 6Mdiet) will be compared on their efficacy on total insulin dose reduction measured at baseline, after 2 weeks and at the end (12 weeks) of both diet interventions
次要结局
- HbA1c(Baseline, 2 weeks and at 12 weeks)
- Overall Glycemia(Baseline, 2 week and at 12 weeks)
- Clock Gene mRNA expression(Baseline, 2 week and at 12 weeks)