Influence of a Liquid Oat Bran Product on Blood Glucose in Patients With Poorly Controlled Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Fasting glucose
研究概览
简要总结
This study evaluates the effects of an ad libitum addition of a high fiber product to the regular diet of type 2 diabetes patients on body weight and blood sugar control. In the first 6 weeks half of the participants will receive the high fiber test product and half a reference product without fiber. After the first 6 weeks both groups will be switched to the high fiber product.
详细描述
It has previously been shown that an increase in the consumption of fiber improves glucose control in type 2 diabetes. In addition, previous pilot studies have shown that a diet solely based on oat flakes can improve insulin sensitivity and glucose control in poorly controlled type 2 diabetes. Recent clinical data indicates, that early hyperglycemia can be normalized by a diet high in fiber. In this controlled pilot study, a food containing liquid oat bran high in fiber will be studied in type 2 diabetes patients with inadequate glucose control that are treated with oral medication or with additional once-daily insulin only against a reference product. 30 patients will be treated with the oat bran product or reference product over a period of 6 weeks in a double blinded approach, hereafter all participants will be switched to the oat bran product. The primary endpoint will be fasting glucose after 6 weeks. Secondary endpoints will be long-term glucose control as measured by HbA1c, self-documented glucose as well as the body weight and body mass index.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The investigator receives reference product and the test product in boxes labelled "stratus" "nimbus" and "cumulus". first 6 weeks participants are randomly assigned to "stratus" or "nimbus" and the second 6 weeks participants all receive "cumulus".
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 with inadequate glucose control and a HbA1c >7,5 and < 9%
- •Treatment with all oral antidiabetic medication or injectable GLP-1 analogues
- •BMI 28,0-39,9 kg/m²
- •Age 30-70 years
排除标准
- •insulin treatment
- •Psychiatric Disease
- •Acute Infections
- •Alcohol or drug abuse
- •Acute diverticulitis
- •Malignant tumors or hematologic disorders
- •Heart failure NYHA III-IV
- •Acute coronary syndrome
- •Chronic kidney disease > Stage 3 (KDOQI)
- •Pregnancy or Lactation
- •Previous bariatric interventions
结局指标
主要结局
Fasting glucose
时间窗: 6 weeks
Change in the concentratino of fasting venous glucose of daily LOB consumption in mg/dl as compared to the change in fasting glucose for the placebo group at 6 weeks.
次要结局
- BMI(12 weeks)
- Weight(12 weeks)
- Inflammation: Il-6(12 weeks)
- HBA1c(12 weeks)
- Fasting glucose(12 weeks)
- Self-documented glucose(12 weeks)
- Lipid metabolism: Serum triglycerides(12 weeks)
- Lipid metabolism: apolipoprotein A (mg/dl)(12 weeks)
- Lipid metabolism: Apolipoprotein B mg/dl(12 weeks)
- Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio(12 weeks)
- Lipid metabolism: HDL-cholesterol(12 weeks)
- Lipid metabolism: LDL- cholesterol mg/dl(12 weeks)
- Microbiome(12 weeks)
- Inflammation: hsCRP(12 weeks)
研究者
Dr. Per Humpert
Director of Stoffwechselzentrum Rhein - Pfalz
Stoffwechselzentrum Rhein - Pfalz