Impact of GLUBLOC on Blood gulcose and insulin levels in patients with diabetes

Phase 2

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2024/05/066846
• Lead Sponsor: My Pura Vida Wellness Private Limited (Puravida)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

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

Inclusion Criteria

Healthy subjects:

1.Aged between 18–60 years,

2.BMI between 18.5 and 22.9 kg/m2

3.Fasting blood glucose range between 3.9 and 5.5 mmol/L.

Diabetes Patients

1.Aged between 18–60 years,

2.BMI between 18.5 and 29.9 kg/m2

3.Fasting blood glucose = 7.2 mmol/L (or) = 126 mg/dl or HbA1C = 6.5%

Exclusion Criteria

Healthy subjects:

1.Women who were pregnant or lactating

2.Any known food allergies

3.Subjects with a bleeding disorder

4.Pre-existing medical condition or taking medication known to affect glucose regulation and/or influence digestion and absorption of nutrients

5.History of diabetes mellitus (type I/II) or they used antihyperglycaemic drugs or insulin to treat diabetes or related conditions

6.Used steroids, protease inhibitors or antipsychotic medicines as these drugs are known to impact glucose metabolism and body fat distribution.

Diabetes Patients:

1.food allergies.

2.Used steroids, protease inhibitors or antipsychotic medicines as these drugs are known to impact glucose metabolism and body fat distribution.

3.Subjects with the history of uncontrolled hypertension and/or hyperthyroidism.

4.History of alcoholism

5.Subjects with psychiatric or neurological disability or mental health disorder

6.Subjects with serious health conditions such as cardiac disease, renal dysfunction, and cancers.

7.Female subjects who are pregnant or had planned for pregnancy in the following months or were breast-feeding.

8.Subjects who refuse to sign informed consent.

9.According to the investigator’s opinion, participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To document the impact of <br/ ><br>GLUBLOC supplementation in patients with diabetes and healthy <br/ ><br>individualsTimepoint: Baseline samples before intervention, end of the 3rd Month and end of the six month

Secondary Outcome Measures

Name	Time	Method
To document adverse effect if any on study productTimepoint: Baseline samples before intervention, end of the 3rd Month and end of the six month