CTRI/2015/07/006015
Not yet recruiting
未知
A clinical study to determine the effect of a dietary fiber on plasma glucose levels in patients with Type II Diabetes Mellitus.
Mr Ajay Nilawar0 sites30 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Mr Ajay Nilawar
- Enrollment
- 30
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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