Effect of nutritional products on glucose response in overweight/obese adults with Type 2 diabetes.
- Conditions
- Health Condition 1: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2019/09/021129
- Lead Sponsor
- Dr Reddys Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Males and/or Female subject with the age group 30 to 65 years.
2. The subject should be diagnosed to have Type II Diabetes Mellitus (at least 3 years in duration)
3. The subject should be overweight/ obese with a Body mass index (BMI) in the range of 23-33 kg/m2
(Asian Indian specific cut offs)
4. The subject should have a Haemoglobin A1c (HbA1c) in the range of 7 % to 10%, done within 3 months of enrolment.
5. The subject should be on treatment with Oral Anti-diabetic medications with stable doses for at least 3 months
6. The subject should be willing to refrain from smoking, alcohol and caffeine containing drinks during the study period.
7. The subject should be willing to comply with study protocol requirements.
8. The subject should be willing to provide a written informed consent.
1. Subject taking Insulin
2. Subject who has been diagnosed to have acute infections like viral fever, typhoid, cold, diarrhoea within one month prior to enrolment.
3. Subject with complications such as respiratory disorders, cancer or heart attack and stroke
4. History of malignancy in the past 1 year.
5. Having any eating disorder or Lactose intolerance
6. History of hypoglycaemia in last 3 months
7. Taking any herbal/Ayurveda/Traditional preparation that could profoundly affect blood glucose
8. Pregnant and lactating women
9. Plans to relocate in the next 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method