Health Condition 1: null- Type II Diabetes Mellitus
Conditions
Interventions
Intervention1: Dietary Fiber: It is a sachet of 5gms. It is to be dissolved in a glass of water and to be taken with meals. Dose: 5 grams twice daily for duration of 4 weeks. (Subject will be instruc
Sponsors
Mr Ajay Nilawar
Eligibility
Inclusion 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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr Almas Pathan
Jehangir Clinical Development Centre Pvt Ltd
Outcome results
None listed