CTRI/2024/07/070100RecruitingUnknown
An open label, randomized, controlled, comparative adaptive clinical study to assess the efficacy of a pro-prebiotic formulation on fasting blood glucose (FBG) and gut microbiome and metabolome in prediabetic, type 2 diabetic and type 2 diabetic with obesity adults. - NI
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Sponsor
- Dr. Reddy’s Laboratories
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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
- •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
Investigators
Similar Trials
Completed
Phase 4
To compare the efficacy and safety of Herbavate vs. the conventional therapy in the management of Palmoplantar Keratoderma.CTRI/2009/091/000756Troikaa Pharmaceuticals Limited150
Completed
Phase 4
To compare the efficacy and safety of Herbavate vs. the conventional steroid therapy in the management of hand dermatitis.CTRI/2009/091/000212Troikaa Pharmaceuticals Limited60
Completed
Phase 3
A 12-week study to determine efficacy and safety of Glycopyrronium Formoterol combination through dry powder inhaler in patients with Chronic Obstructive Pulmonary DiseaseCTRI/2017/08/009286Cipla Ltd356
Not yet recruiting
Not Applicable
A study to compare the benefits between itraconazole and terbinafine with itraconazole in skin fungal infectionsCTRI/2022/12/047904nil
Completed
Phase 2
Clinical trails in subjects with bacterial infection.CTRI/2023/02/049817JAGDALE INDUSTRIES PVT. LTD30