Effect of Diabetes Specific Protein Supplement (DSPS) on post prandial glycemic responses in individuals with type 2 diabetes: A randomized single center crossover study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Post prandial glucose response (iAUC)
研究概览
简要总结
Prevalence of type 2 diabetes mellitus has been increasing at an alarming level with nearly 101 million Indians living with diabetes in India as per latest ICMR-INDIAB report. With such a high incidence, only 7.7% of individuals with diabetes are found to achieve all three ABC target (HbA1c, blood pressure and LDL- cholesterol levels). This indicates that achievement of targets and adoption of healthy behaviors remains sub-optimal in India.
In people with T2DM, blood glucose levels are usually higher in the morning than at other times of the day.Additionally, commonly consumed breakfast items in India like upma and poha are rich in simple carbohydrates and lack protein and fiber.
In a high carbohydrate consuming nation like India, meeting dietary protein requirements can be a challenge especially for vegetarians.
Increasing intake of dals/pulses in a vegetarian diet may not be an effective solution as a lot of people experience bloating and gas. Dairy products are also advised to be consumed in moderation since they are rich in calories and saturated fat. Even non-vegetarians struggle to meet their requirement as the consumption is strongly influenced by religion and cultural practices and so the frequency of consumption may not be sufficient enough to meet the daily protein requirements. To bridge this gap between the intake and requirement, Diabetes Specific Protein Supplement (DSPS) can be useful if dietary sources are not sufficient.
This study therefore aims to assess whether the post meal glycemic response with partial meal replacement using DSPS at breakfast is lower compared to an isocaloric control breakfast in individuals with type 2 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •People with T2D (with duration of diabetes morethan 6 months) and treated with oral antidiabetic drugs stable for at least 2 months or controlled with diet alone.
- •HbA1c 7-9% (7 & 9% included) In case of People with T2D with hypertension, it needs to be treated and well controlled.
- •In case of People with T2D with dyslipidemia, it needs to be treated and well controlled.
- •BMI between 18.5-29.9 (18.5 & 29.9 included) People on home remedies or taking diabetes specific nutrition formula would be asked to practice abstinence from these foods/formulations at least for a week before study and during the study.
- •Willing to comply with the study protocol Written informed consent.
排除标准
- •People with Type 1 DM People with Type 2 DM on insulin or acarbose or short acting sulfonylurea (e.g.meglitinide) medication or GLP 1 analogues Pregnant women Lactating mothers People with uncontrolled diabetes, HbA1c more than 9.0.% People with significant heart disease (uncontrolled dyslipidemia.
- •fasting S. cholesterol more than 260mg /dL and S. triglycerides more than 300mg/dL) on screening visit People with presence of any severe diabetic complication and/or major systemic disease. People with renal disease, S. Creatinine more than 1.5mg/dL, requiring dialysis People with liver disease, AST and ALT more than 2.5times the upper normal limits People with recent history of stroke or unstable angina or coronary artery diseases in the last six months before inclusion. Presence of ketone bodies in urine analysis. People with IBS, IBD, chronic acidity, and bloating Hemoglobin level below 10 gm%. History of substance abuse or alcoholism in the past one year. People who have been infected with HIV/Hepatitis B or Hepatitis C or COVID in the last 3 months as per information given by people. People who had a major infection in the past 3 weeks and have been treated with antibiotics. People who are on corticosteroids or oral contraceptives. People in any clinical trials within 30 days of admission to the study. Known allergies or intolerance to milk, soy, lactose or any component of the test product People following veganism. People with IBS, IBD, chronic acidity, and bloating.
结局指标
主要结局
Post prandial glucose response (iAUC)
时间窗: at baseline 0 min and post-meal at 30, 60, 90, 120,150 and 180 min
次要结局
- Post prandial insulin area under the curve, Postprandial peak glucose (mg/dl), Postprandial peak insulin (µU/mL), Maximum postprandial glucose increase from baseline (delta peak), Maximum postprandial insulin increase from baseline (delta peak)(at baseline 0 min and post-meal at 30, 60, 90, 120,150 and 180 min)
研究者
Dr Shobha A Udipi
Kasturba Health Society Medical Research Center