Effectiveness of Low carb products in mitigating blood sugar spikes in patients with Type 2 Diabetes Mellitus.
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2023/05/053173
- Lead Sponsor
- Bajo Foods Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Male and female subjects aged 30-55 years both inclusive.
2.Subjects with history of prediabetes (5.7-6.4%) and Diabetes mellitus â?? type II for 1-15 years.
3.Diabetics with HbA1c >7.5%
1.History of hypersensitivity to any of the study treatments, excipients, or drugs of similar chemical classes including sulfonylureas and meglitinides
2.History of type 1 diabetes
3.Subjects on insulin therapy
4.Subjects with the history of uncontrolled hypertension and/or hyperthyroidism
5.History of alcoholism
6.Subjects with psychiatric or neurological disability or mental health disorder
7.Subjects with serious health conditions such as cardiac disease, renal dysfunction, and cancers.
8.Female subjects who are pregnant or had planned for pregnancy in the following months or were breast-feeding.
9.Subjects who refuse to sign informed consent.
10.Those who have participated in another clinical trial within 1 month of visit 1 or plan to participate during the clinical trial period.
11.According to the investigatorâ??s opinion, participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable.
12.Any planned surgery during study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method