NCT06496893尚未招募不适用
A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Glucocil® on Metabolic Health in Individuals With Prediabetes and Type 2 Diabetes Mellitus.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- Cohort 2- (Type 2 diabetes mellitus (T2DM)) To assess the effect of Investigational Product (IP) on blood sugar as assessed by Glycated haemoglobin (HbA1c) in individuals with Type 2 diabetes mellitus (T2DM).
研究概览
简要总结
A randomized, double-blind, placebo-controlled study to assess the effect of Glucocil® on metabolic health in individuals with prediabetes and Type 2 Diabetes Mellitus.
详细描述
A randomized, double-blind, placebo-controlled study to assess the effect of Glucocil® on metabolic health in individuals with prediabetes and Type 2 Diabetes Mellitus
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)
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
- 是
入选标准
- •Males and females of age more than equal to 30 years and less than equal to 70 years.
- •Body mass index within 30 kg/m2 and 35 kg/m2 (both values included) with waist circumference above 40 inches (men) or 35 inches (women).
- •Cohort 1 (Only for prediabetes individuals)- Individuals diagnosed with prediabetes with OGTT (140 mg/dL to 199 mg/dL); HbA1c (5.7% to 6.9%) and fasting blood glucose level (between 100 mg/dL to 125 mg/dL).
- •Cohort 2 (T2DM)- Individuals newly diagnosed with Type 2 diabetes mellitus with HbA1c between 7% and 9% (both values included) and fasting blood glucose level in between 126 to 180 mg/dL.
- •Triglycerides between 150 mg/dL and 299 mg/dL (both values inclusive) and/or Low-Density Lipoprotein (LDL) in between 130 mg/dL and 189 mg/dL (both values inclusive).
- •Individuals having non-vegetarian diet for at least 2 days a week.
- •Non-smoker.
- •Individuals who are willing to not change their physical activity levels throughout the study period.
- •Individuals willing to complete all study-related questionnaires and to complete all clinical study visits.
- •Individuals ready to give voluntary, written informed consent to participate in the study.
排除标准
- •Individuals who are exclusively vegetarians diet.
- •Individuals with Type 1 diabetes mellitus.
- •Individuals with Type 2 diabetes mellitus on medication.
- •Individuals with any other endocrine disorder.
- •Individuals who are currently on diuretics or thyroid supplements
- •Individuals on lipid-lowering therapies.
- •Individuals with uncontrolled hypertenstion as assessed by systolic over diastolic blood pressure (≥ 140/90 mmHg).
- •Individuals who are currently on antihypertensive medication.
- •Individuals with cardiac arrhythmia, impaired hepatic or renal function
- •Individuals having heart failure, coronary artery disease, hyperthyroidism, hypothyroidism, cancer or mental disease or any other serious disease requiring active treatment.
- •History of malignancy or stroke.
- •Chronic alcoholism: History and/or current cases of chronic alcohol consumption or heavy drinkers as defined by i.For men consuming more than 4 drinks on any day or more than 14 drinks/week ii. For women, consuming more than 3 drinks on any day or more than 7 drinks/week
- •Individuals taking concomitant medication known to alter blood sugar.
- •Individuals having treatment with herbal or any other supplements.
- •Any condition or abnormality that would compromise the safety of the individuals or the quality of the study data.
- •Use of another investigational product within 3 months of the screening visit.
- •Females who are lactating, pregnant or planning to be pregnant or taking any oral contraceptives
结局指标
主要结局
Cohort 2- (Type 2 diabetes mellitus (T2DM)) To assess the effect of Investigational Product (IP) on blood sugar as assessed by Glycated haemoglobin (HbA1c) in individuals with Type 2 diabetes mellitus (T2DM).
时间窗: Screening visit (The same value will be considered for baseline) and Day 90.
HbA1c reference ranges for prediabetes is between 5.7 to 6.4% for type II diabetes mellitus, it is between 7 to 9%.. For the current study, impaired range of Hba1c from 6.5 to 6.9% shall be consider as prediabetes
次要结局
- Cohort 1 (Prediabetes) & Cohort 2 (T2DM): To assess the effect of Investigational product (IP) on Pancreatic efficiency as assessed by the change in the fasting insulin(Day 0, Day 30, Day 60, Day 90)
- Cohort 1- ( Pre-diabetes) To assess the effect of Investigational Product (IP) on blood sugar in Pre-diabetes as assessed by 2-hour plasma glucose level by Oral Glucose Tolerance Test(Screening visit (The same value will be considered for baseline) and Day 90.)
- Cohort 1 (Prediabetes) & Cohort 2 (T2DM): To assess the effect of Investigational product (IP) on Change in Fasting Blood Glucose (FBG)(Day 0, Day 30, Day 60, Day 90)
- To assess the effect of Investigational product (IP) on:Lipid profile [total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides](Screening visit (The same value will be considered for baseline) and Day 90.)
- Cohort 1 (Prediabetes) & Cohort 2 (T2DM): To assess the effect of Investigational product (IP) on Percentage change in body weight by weighing scale(Day 0, Day 30, Day 60, Day 90)
- Cohort 1 (Prediabetes) & Cohort 2 (T2DM): To assess the effect of Investigational product (IP) on Change in central obesity as assessed by the change in the anthropometric index of waist-to-height ratio(Day 0, Day 30, Day 60, Day 90)
- Cohort 1 (Prediabetes) & Cohort 2 (T2DM): To assess the effect of Investigational product (IP) on Change in the Eating behavior as assessed by Three factor eating questionnaire - Revised 18(Day 0, Day 30, Day 60, Day 90)
- Cohort 1- ( Pre-diabetes) To assess the effect of Investigational Product (IP) on blood sugar as assessed by Glucose metabolism as assessed by change in the HbA1c(Screening visit (The same value will be considered for baseline) and Day 90.)
- Cohort 1 (Prediabetes) & Cohort 2 (T2DM): To assess the effect of Investigational product (IP) on Change in Quality of life as assessed by SF- 6Dv2TM Health Survey(Day 0, Day 30, Day 60, Day 90)
研究者
研究点 (9)
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