Study of dietary fiber to improve blood sugar levels in patients having Type II Diabetes

Not Applicable

• Conditions: Health Condition 1: null- Type II Diabetes Mellitus

• Registration Number: CTRI/2015/07/006015
• Lead Sponsor: Mr Ajay Nilawar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

•Males and females 18 -65 years of age (both inclusive).

•Diagnosed with type 2 diabetes mellitus

•Fasting sugar greater than equal to 126 mg/dl and/or PP sugar greater than equal to 200 mg/dl

•Stable dose of the anti-diabetic treatment in a period of 30 days prior to screening.

•No plan to change the anti-diabetic treatment during subjectâ??s participation in the study as judged by the Investigator at screening.

•BMI less than or equal to 30 kg/m².

•Must have adequate reports of the fasting and PP sugars of past 1 month from screening.

•Must be willing to or likely to comply with all study requirements.

•Must be able and willing to provide written informed consent.

•Females of childbearing potential should have a negative pregnancy test at the time of screening and agree to use contraception during the study.

Exclusion Criteria

•Use of insulin.

•Suffering from any chronic diseases or serious complications that may interfere with glucose metabolism which in opinion of the Investigator precludes trial participation.

•Suffering from gastrointestinal diseases which in opinion of the Investigator may interfere with nutrient absorption, distribution, metabolism and excretion e.g. subacute obstruction.

•Current use of medication which in opinion of the Investigator may interfere with the digestion and nutrient absorption (for examples steroids, protease inhibitors or antipsychotics medications).

•Current use of medication which in opinion of the Investigator is known to affect glucose tolerance (excluding oral contraceptives) and glucose estimation.

•Known food allergy or intolerance, abuse of drugs or alcohol.

•Known case of sensitivity to Gluten or Coeliac disease.

•Pregnant or lactating females.

•Presence of any clinically significant medical conditions or medications which in the opinion of the investigator would make the subject unsuitable for participation in the study.

•Currently participating or had participated in any other interventional study in last 1 month prior to screening

•Patients who are unlikely to comply with protocol requirements (e.g. non-cooperative behavior, inability to attend study visits required by the protocol).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the effect on the fasting and post prandial (PP) in patients with Type II Diabetes Mellitus.Timepoint: Week 2, 3 and 4

Secondary Outcome Measures

Name	Time	Method
ilTimepoint: Nil