Metabolic Response to a LoBAG30 Diet in Diabetic Patients on Metformin
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Body Weight at 5 Weeks From Baseline
研究概览
简要总结
We will determine the metabolic response to a Low Biologically Available Glucose Diet (LoBAG30) in subjects currently receiving the maximum dose of metformin as monotherapy in whom the glycohemoglobin is not at an acceptable level (>8.0%). Our hypothesis is that introduction of a LoBAG30 diet to subjects currently treated with a full therapeutic dose of metformin will improve blood glucose control in people who have not achieved an acceptable total glycohemoglobin on metformin alone.
详细描述
Subjects will ingest a control diet (55% carbohydrate (CHO), 15% protein, 30% fat) or a LoBAG30 diet (30% CHO, 30% protein, 40% fat) in a parallel design with block randomization in pairs of two. Subjects will return to the study center twice each week while on the diets to have blood glucose, glycohemoglobin, lactate, weight and blood pressure measured, and to have urine assayed for urea and creatinine. At the beginning and end of the 5 week study period, the subjects will be admitted to the study center for 28 hours during which time blood will be drawn for 24 hour profiles of glucose, insulin, other hormones and several metabolites. For those subjects randomized to the LoBAG30 arm of the study, the control diet will be given during the first 24 hour study period; the assigned diet will be given at the end of the 5 week period.
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People with type 2 diabetes mellitus who currently are receiving the maximal dose of metformin monotherapy (2500 mg/day).
- •These subjects will have had a stable glycohemoglobin (tGHb) in an unacceptably high range (8-11%) for at least 4 months prior to beginning the study.
- •Subjects with tGHB > 11% (HbA1c > 10%) will not be recruited into the study.
排除标准
- •Hematological abnormalities
- •liver disease
- •kidney disease
- •macroalbuminuria (>300 mg albumin/24 hours)
- •untreated thyroid disease
- •congestive heart failure
- •life-threatening malignancies
- •proliferative retinopathy
- •severe diabetic neuropathy
- •peripheral vascular disease
- •serious psychological disorders
- •a body mass index > 35
- •and a fasting triglyceride of >400 mg/dl.
- •Subjects taking slow-release metformin will not be studied.
- •Subjects taking medications other than metformin, known to affect fuel metabolism such as:
- •the sulfonylureas
- •glucagon-like peptide 1 (GLP-1) analogs and metabolic inhibitors
- •pramlintide
- •prednisone and similar steroids
- •thyroid hormone
- •antipsychotic medications
- •thiazide diuretics
- •medroxyprogesterone
- •high dose aspirin, also will be excluded.
- •If concentrations of serum folate, B12 or iron are low, the subject will be excluded from the study until corrected, i.e. until normal concentrations are recorded.
结局指标
主要结局
Change in Body Weight at 5 Weeks From Baseline
时间窗: baseline and 5 weeks after dietary intervention
Subjects were to remain weight stable. We expected less than 2 pound weight change over 5 weeks. Weight was measured before dietary intervention, and after 5 weeks of dietary intervention.
Change in Overnight Fasting Glucose Concentration at 5 Weeks From Baseline
时间窗: baseline and 5 weeks after dietary intervention
Overnight fasting glucose concentration was measured before dietary intervention and after 5 weeks of dietary intervention.
Change in %Hemoglobin A1c at 5 Weeks From Baseline
时间窗: Baseline and 5 weeks after dietary intervention
Hemoglobin A1c measured before and after 5 weeks on the diet
Change in Total Glucose Area at 5 Weeks From Baseline
时间窗: Baseline and 5 weeks after dietary intervention
The area response is measured using zero as baseline. The area is measured before dietary intervention, and following 5 weeks of dietary intervention.
次要结局
- Change in Fasting Triglycerides at 5 Weeks From Baseline(baseline and 5 weeks after dietary intervention)
- Microalbumin Excretion(baseline and 5 weeks after dietary intervention)