Clinical study of nutritional formulations in prediabetes and type 2 diabetes mellitus.

Phase 2

• Conditions: Health Condition 1: E139- Other specified diabetes mellituswithout complications

• Registration Number: CTRI/2024/07/070146
• Lead Sponsor: ife Synergy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified