A randomized, double-blind, placebo-controlled clinical trial to assess the safety and efficacy of nutritional formulations in prediabetes and type 2 diabetes mellitus (T2DM).
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 1.Changes in Glycemic profile by assessing
研究概览
简要总结
Prediabetes and T2DM is a chronic metabolic disorder characterized by insulin resistance and hyperglycemia, leading to various complications affecting multiple organ systems. Despite the availability of OHAs, achieving and maintaining glycemic control in T2DM patients remains a challenge. Therefore, there is a continuous need for nutritional approaches that can effectively manage Prediabetes and T2DM while minimizing adverse effects and improving patients quality of life.
This randomized, double blind, placebo controlled, parallel arm clinical trial aims to address this gap in knowledge by evaluating the safety and efficacy of nutritional formulation in Prediabetes and T2DM patients.
The study incorporates a wide range of outcome measures, including glycemic profile, insulin resistance, lipid metabolism, metabolic syndrome severity, anthropometric parameters, diabetes-related quality of life and safety assessment. By examining multiple endpoints, the study provides a holistic evaluation of nutritional formulations impact on various aspects of Prediabetes and T2DM management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female participants between age 30-65 years (both inclusive); 2.Participants with a BMI of more than 28 and less than 35 kg/m2; 3.Participants with or without deranged lipid profile; For diabetic subjects 1.Participants receiving oral hypoglycemic agents (OHA) biguanides and sulfonylureas (only combination)Newly diagnosed participants who are eligible for inclusion may begin the trial with investigational product monotherapy.
- •In the event of poor glycemic control, or safety concerns, the investigator may initiate standard-of-care treatment for type 2 diabetes mellitus; 2.Glycated haemoglobin (HbA1c) greater than 6.5% and less than 8% (both inclusive); 3.Fasting Plasma Glucose (FPG) greater than 130 mg/dL and less than 250 mg/dL (both inclusive); 4.Participants willing to comply with the study procedure and sign written informed consent; For pre-diabetic subjects 1.Participants with Hemoglobin A1c (HbA1c) greater than or equal to 5.7 % and less than or equal to 6.4%; 2.Participants with Fasting Plasma Glucose (FPG) between 100-125 mg/dl (both inclusive), post meal plasma glucose value between 140-199 mg/dl (both inclusive); 3.IDRS (Indian Diabetics Risk score) less than or equal to 60.
排除标准
- •1.Participants with concurrent serious hepatic dysfunction (defined as AST and or ALT more than 3 times of the upper normal limit) or renal dysfunction (defined as S.
- •creatinine more than 1.4 mg per dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease, 2.Participants suffering from major systemic illness necessitating long term drug treatment including but not limited to hematologic condition (eg., hemolytic anemias, sickle cell anemia), acute myocardial infarction, unstable angina, uncontrolled hypertension, congestive heart failure (class 3 or class 4 NYHA), or cerebrovascular accident, psychiatric or neurological disorder, autoimmune condition, received chronic (more than 14 days) therapy with systemic glucocorticoids (excluding topical, intraocular, intranasal, intra articular, or inhaled preparations) within six months prior to enrollment, 3.Smokers,Alcoholics and or drug abusers, 4.Participants with evidence or history of malignancy, 5.Involvement in any other clinical trial requiring drug therapy, 6.Pregnant or lactating women or women of fertile age not using effective contraception, 7.Any condition that could, in the opinion of the investigator, preclude the participants ability to complete the study or that may confound study outcomes.
- •For diabetic subjects 1.Type 1 diabetes, 2.Receiving antidiabetic drugs except for those specified in the inclusion criteria including Insulin treatment, For pre-diabetic subjects 1.Participants with type 1 or type 2 diabetes mellitus (T2DM), gestational diabetes (GDM), or secondary diabetes, 2.Participants with any other co-morbidity, 3.Participants treatment with a glucose lowering or weight loss agent (s) within 90 days before screening.
结局指标
主要结局
1.Changes in Glycemic profile by assessing
时间窗: From screening to end of the study.
a) Fasting, and post-meal plasma glucose levels from screening to the end of the study and
时间窗: From screening to end of the study.
b) HbA1c levels
时间窗: From screening to end of the study.
2.Changes in Insulin resistance by assessing Fasting insulin, HOMA-IR score
时间窗: From screening to end of the study.
次要结局
- 1.Changes in lipid metabolism by assessing cholesterol, LDL, HDL, Triglycerides etc.(2.Changes in Metabolic Syndrome Severity Z Score.)
研究者
Dr Amol Gothwad
Lokmanya Medical Research Centre and Hospital