CTRI/2015/07/006015Not yet recruitingNot Applicable
A clinical study to determine the effect of a dietary fiber on plasma glucose levels in patients with Type II Diabetes Mellitus.
Mr Ajay Nilawar1 site in 1 country30 target enrollmentStarted: July 20, 2015Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- To determine the effect on the fasting and post prandial (PP) in patients with Type II Diabetes Mellitus.
Study Overview
Brief Summary
This is a study in subjects with Type II diabetes mellitus.The main purpose of this study is to determine the effect of a dietary fiber in patients with type II Diabetes mellitus.Subjects who meet the eligibility criteria will be enrolled into the study. At the screening visit, retrospective data of subject’s blood sugars will be collected. In addition, fasting and PP sugars will be assessed at screening, week 2/ day 15, week 3/Day 22 and week 4/Day 29.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •â€¢Males and females 18 -65 years of age (both inclusive).
- •â€¢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.
- •â€¢No plan to change the anti-diabetic treatment during subject’s participation in the study as judged by the Investigator at screening.
- •â€¢BMI less than or equal to 30 kg/m².
- •â€¢Must have adequate reports of the fasting and PP sugars of past 1 month from screening.
- •â€¢Must be willing to or likely to comply with all study requirements.
- •â€¢Must be able and willing to provide written informed consent.
- •â€¢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
- •â€¢Use of insulin.
- •â€¢Suffering from any chronic diseases or serious complications that may interfere with glucose metabolism which in opinion of the Investigator precludes trial participation.
- •â€¢Suffering from gastrointestinal diseases which in opinion of the Investigator may interfere with nutrient absorption, distribution, metabolism and excretion e.g. subacute obstruction.
- •â€¢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).
- •â€¢Current use of medication which in opinion of the Investigator is known to affect glucose tolerance (excluding oral contraceptives) and glucose estimation.
- •â€¢Known food allergy or intolerance, abuse of drugs or alcohol.
- •â€¢Known case of sensitivity to Gluten or Coeliac disease.
- •â€¢Pregnant or lactating females.
- •â€¢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).
Outcomes
Primary Outcomes
To determine the effect on the fasting and post prandial (PP) in patients with Type II Diabetes Mellitus.
Time Frame: Week 2, 3 and 4
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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