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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Mean change in incremental Area Under the Curve (iAUC) on Ambulatory Glucose Profile using Continuous Glucose monitoring from baseline to 12 weeks
研究概览
简要总结
Randomized parallel arm study with 172 adults with type 2 diabetes. This is an open label, prospective, randomized controlled study. Participants fulfilling the eligibility criteria will be enrolled in the study.
Participants will be screened and all the eligible participants will be put on 4 days run-in period of test product (Prohance-D) to check compliance. This will be followed by 10 days washout period. Participants will then be randomized (computer generated random numbers) into either of following 2 arms:
· Intervention/Test Arm (Group A): Prohance-D (Diabetes Specific Nutritional Supplement) + Standard of Care (Diabetes treatment along with Life Style modification and Diet as per diet prescription and calories adjusted with IP’s calories)
· Control Arm (Group B): Standard of Care (Diabetes treatment along with Life Style modification and Diet as per diet prescription)
All the participants will be instructed not to make any major modifications in their routine diet and physical activity and refrain from feasting and fasting during the study period
Anthropometric, clinical, biochemical, dietary and physical activity levels will be assessed at periodic time intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
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.
结局指标
主要结局
Mean change in incremental Area Under the Curve (iAUC) on Ambulatory Glucose Profile using Continuous Glucose monitoring from baseline to 12 weeks
时间窗: 2 time points baseline and end of 12 weeks study period.
次要结局
- Proportion of participants with adverse events and serious adverse events(7 time points start from day 1 and every week of the study)
- Change in CGM variables such as Mean amplitude of Glycemic excursions (MAGE),Time in Range (TIR),Time above range (TAR),Time below range (TBR),Mean blood glucose(2 time points baseline and end of 12 weeks study period.)
- Mean change in HbA1C levels(2 time points baseline and end of 12 weeks study period.)
- Mean changes in fasting blood glucose levels(4 time points baseline,4,8 and end of 12 weeks study period.)
- Mean changes in post prandial blood glucose levels(2 time points baseline and end of 12 weeks study period.)
- Mean changes in anthropometric measurement (weight, BMI & waist circumference)(Anthropometric measurements will also be measured monthly once)
- Mean changes in lipid profile [total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides](2 time points baseline and end of 12 weeks study period.)
- Mean change in plasma fatty acids level in a sub sample of 60 participants (30 in each arm)(2 time points baseline and end of 12 weeks study period.)
- Change in participant-reported outcomes on satiety using satiety rating scale(4 time points baseline,4,8 and end of 12 weeks study period.)