CTRI/2023/11/059866尚未招募Unknown
Effect of low glycemic index Diabetes Specific Nutritional Supplement on Glycemic Control in Indian Adults with Type 2 Diabetes Mellitus: A Randomized, Controlled Trial (PRIDE II) - PRIDE II
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
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
- •Age: 30- 65 years old male and non-pregnant females
- •Diagnosis of Type 2 Diabetes Mellitus for at least 1 year; treated with stable dose of oral anti-diabetic drugs (drugs permitted: metformin, sulfonylureas, Thiazolidinediones, DPP-IV inhibitors, AGIs) for at least 3 months before screening.
- •Participants with HbA1c from 8 to 11%
- •Body mass index (BMI) =25 kg/m2
- •Participant willing to provide informed consent and willing to comply with study procedures
排除标准
- •Type 1 Diabetes Mellitus participants.
- •Type 2 Diabetes Mellitus participants on insulin, GLP-1 agonists and/or SGLT2 inhibitors.
- •Allergy to one or more components of the investigational product or history of food allergies
- •Participant receiving any diabetes specific nutritional food supplement apart from multivitamin/ mineral supplements (Ca/Vit D supplements and B complex syrups) within 15 days prior to study start.
- •Participant taking any herbal/ ayurvedic/ alternative medicine preparations that could profoundly affect blood glucose.
- •Females who are nursing / pregnant / are of child - bearing potential and not practicing an acceptable method of birth control / or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
- •Participant has evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease, which in the opinion of the investigator, can adversely affect study outcome/s.
- •Participant with active infection in past 30 days.
- •Participant with history of acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) infection.
- •Participant has a history of any episode(s) of severe hypoglycemia (requiring third party assistance), disabling diabetic neuropathy including autonomic neuropathy, gastroparesis or lower limb ulceration or amputation or evidence or history of diabetic complications with significant end organ damage.
- •Participant has a history of illicit drug or alcohol abuse within last 1 year.
- •Participants on therapy with the following drugs will not be permitted to participate in the trial: DRUGS CAUSING HYPERGLYCEMIA (Thiazides, Glucocorticoids, Diazoxide, Glucagon, Phenytoin, Tacrolimus, Niacin, L-asparaginase, Cyclosporine, Protease inhibitors) and DRUGS CAUSING HYPOGLYCEMIA (Quinine, Insulin, Ethanol, Octreotide, Salicylates-late in overdose), currently or within past 3 months from the time of screening
- •Participants on any pharmacological therapy of modern or alternative medicine for management of obesity in past 6 months.
- •Participants with history of bariatric surgery.
- •Participant has any major or minor surgery within 30 days prior to screening.
- •Participant has a history or confirmed diagnosis of malignancy.
研究者
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