CTRI/2024/08/072006尚未招募2 期
Effect of Diabetes Specific Protein Supplement (DSPS) on post prandial glycemic responses in individuals with type 2 diabetes: A randomized single center crossover study. - NI
utricia International Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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.
研究者
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