Health Condition 1: - Health Condition 2: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Pro-Prebiotic Supplement: Prediabetes- 4g/Sachet
Duration: 1 Sachet / per day (after food without water. Subject need to empty the sachet in mouth and it will dissolve)
Total Duration: 30 Days for Pilot Phase and 90 Days for Exploratory Phase
Inter
Sponsors
Dr. Reddy’s Laboratories
Eligibility
Inclusion criteria
Inclusion criteria: Type of Participant and Disease Characteristics 1 General Criteria for all categories Male and Female subjects with age 18 years to 55 years both inclusive Are willing to sign the informed consent and adhere to the study protocol for the duration of the study 2 Pre-diabetics HbA1c in the range of 5.7 to less than or equal to 6.4 percentage FBG in the range 110 to 125 mg per dl or PPG in the range 140 to199 mg per dl With BMI greater than or equal to 18.5 to 28.0 3 Diabetics HbA1c greater than or equal 6.5 to less than or equal to 9 percentage FBG greater than or equal 126 mg per dl or PPG greater than or equal 200 mg per dl With normal BMI in the range greater than or equal to 18.5 to less than or equal to 24.9 Before entry into the study and throughout in study the subject should be on stable antidiabetic medication for at least 12 weeks 4 Diabetics plus Obesity HbA1c greater than or equal to 6.5 to less than or equal to 9 percentage FBG greater than or equal 126 mg per dl or PPG greater than or equal 200 mg per dl With BMI greater than or equal to 25 Before entry into the study and throughout in study the subject should be on stable antidiabetic medication for at least 12 weeks 5 Healthy HbA1c less than 5.7 percentage FBG greater than or equal 110 mg per dl or PPG greater than or equal 140 mg per dl With BMI in the range greater than or equal to 18.5 to less than or equal to 24.9 Healthy subjects with no ongoing comorbidities
Exclusion criteria
Exclusion criteria: Medical Conditions and Prior medication Type 1 diabetes mellitus Concomitant autoimmune disorders, liver conditions, gastrointestinal disorders (i.e., irritable bowel syndrome, inflammatory bowel disease and coeliac disease etc.), GI injury or any other GI disorder that can interfere with absorption etc of the pro-prebiotic supplement. Recent use (within the previous 8 weeks of date of Informed Consent Form) of antibiotics, steroids and dietary supplements (fish oil, probiotics, prebiotics, multivitamins, minerals, nutraceuticals and herbal preparations) Pregnancy, breastfeeding or planning to become pregnant Alcohol abuse or the use of any illicit drugs Clinical evidence of active infection or any severe illness unrelated to diabetes. Any other condition in the opinion of a Principal Investigator which may interfere with study results and affects the subject safety. Diabetes or Diabetes plus Obesity subjects on insulin or Alpha Glucoside Inhibitors Prediabetic subjects on metformin Subjects on weight loss diets or taking any sort of supplements for weight loss Patients with history of or any ongoing food allergies or any other allergies Subjects eating outside food (ie from hotels/mess etc) less than or equal to4 times in a week Subjects who are settled in a region or migrated from north or east region of India People whose daily diet is too light or too greasy are not recommended to participate in the test Subject who are Lactose or Gluten or casein intolerant No oral poisoning to the individual No ongoing Immunosuppressive Medications and such other treatments No diarrhea, fever or other clear inflammatory reactions within the last one week of date of ICF
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For Pilot Phase: To study the effect of pro-prebiotic formulation on the FBG For Exploratory Phase: To study the effect of pro-prebiotic formulation on the FBG Timepoint: For Pilot Phase: To estimate the trend in change in FBG from baseline to 1 month [Time Frame: Baseline, 30 days] For Exploratory Phase: To estimate the change in FBG of the test arm in comparison to the standard control [Time Frame: Baseline to 90 days] | — |
Secondary
| Measure | Time frame |
|---|---|
| For Exploratory Phase To study safety of the pro prebiotic formulation Timepoint: For Exploratory Phase To assess the safety of pro-prebiotic formulation in terms of incidences of AE/SAE, Physical examination, LFT & RFT [Time Frame: Baseline to 90 days];For Exploratory Phase To study the effect of pro prebiotic formulation on Change in body weight waist & hip circumference waist–hip ratio & body mass index in diabetic obesity group onlyTimepoint: For Exploratory Phase Change in body weight, waist & hip circumference, waist–hip ratio & body mass index Time Frame: Baseline, 30 days, 60 days, 90 days ;For Exploratory Phase To study the effect of pro prebiotic formulation on the HOMA-IR Timepoint: For Exploratory Phase To estimate the change in HOMA-IR of the test arm in comparison to the standard control [Time Frame: Baseline, 30 days, 60 days, 90 days];For Exploratory Phase To study the effect of pro prebiotic formulation on the inflammatory biomarkers Timepoint: For Exploratory Phase To estimate the change in IL-1, TNF-alpha & CRP of the test arm in comparison to the standard control [Time Frame: Baseline to 90 days];For Exploratory Phase To study the effect of pro prebiotic formulation on the lipid profileTimepoint: For Exploratory Phase To estimate the change in LDL HDL Total Cholesterol TC TC or HDL & Triglycerides of the test arm in comparison to the standard control Time Frame: Baseline to 90 days ;For Exploratory Phase To study the effect of pro prebiotic formulation on the fasting insulin To study the effect of pro prebiotic formulation on PPG To study the effect of pro prebiotic formulation on the HbA1c Timepoint: For Exploratory Phase To estimate the change in fasting insulin of the test arm in comparison to the standard control [Time Frame: Baseline, 30 days, 60 days, 90 days] To estimate the change in PPG of the test arm in comparison to the standard control [Time Frame: Baseline, 30 days, 60 days, 90 days] | — |
Countries
India
Contacts
Public ContactDr Vinita Satyavrat
Dr. Reddy’s Laboratories
Outcome results
None listed