Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications
Conditions
Interventions
Intervention1: GlucoSEB PB: 500mg, 2 capsules per meal
(lunch and dinner), oral route of administration, swallow as a whole with water just before
having meal, for 180 days
Control Intervention1: Plac
Sponsors
Advanced Enzymes Technologies Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with less physical activity 2. BMI 18.5 to 35 Kg/m2 3. Subjects with recent HbA1c reports within 2 weeks can be considered as screening value for participation in the study. 4. Subjects taking stable medicine dose for past 3 months 5. Subjects who occasionally consume sweets 6. Subjects with fasting blood sugar level =130 mg/dL and HbA1c 7.0 to 11.0% 7. Subjects must have a history of diabetes for more than 1 year and have been on a stable medication regimen for at least the past 9 months 8. Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating female. 2. Subjects with BMI greater than or equal to 35 3. Type I diabetic patients 4. HbA1c less than 7.0 and greater than 11.0% 5. Diabetes medication (DPP4 inhibitors, Acarbose, Voglibose, Repaglinide, GLP1 receptor agonists (GLP1RA), and Insulin) 6. Patients with major chronic complications (including but not limited to) autoimmune disease, inflammation, etc. 7. Organic insufficiency (cardiac, hepatic, renal, respiratory) 8. Use of food supplements specifically containing fibers or polysaccharides 9. Chronic smoking and alcohol intake 10. Allergy to the ingredients in the test product. 11. History of any surgery in the past 3 months. 12. Subject currently taking or has in the past 30 days used GI related probiotics or prebiotics or any enzymes [prescription or over the counter (OTC)].
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c (assessment on Day -1 to Day -7, Day 90 and Day 180)Timepoint: 180 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 10. CBC analysis on Day 1, Day 90 & Day 180, & vital sign measurement (assessment on every visit). 11. Monitoring subjects for any side effects occurred during the treatment. (weekly follow up- telephonic or paper record) 12. Tolerability- The tolerance of the product by participants assessments for any side effect such as Nausea, Vomiting, Bloating, Abdominal cramps & heartburn experienced during the study. The tolerability will be evaluated by the intensity of each individual symptom on a validated 5-point Likert scale (0-no problem, 1-mild problem, 2-moderate problem, 3-severe problem & 4-very severe problem) 13. Rate of incidence of AE & SAEs- Recording any adverse (AE) or serious adverse event (SAE) from Day 1 to Day 180Timepoint: 180 days;1. Change in fasting blood glucose (assessment on Day -1 to Day -7, Day 90 & Day 180). 2. Change in fasting insulin (assessment on Day 1, Day 90 & Day 180) 3. Calculate- HOMA-IR score- fasting insulin (?IU per ml) X fasting glucose (mmol per L) divided by 22.5 a. beta-cell function (HOMA-beta)- [20 X Fasting insulin (microIU/mL)] divided by [Fasting glucose (mmol per L) ? 3.5] b. Disposition index (DI)- DI is equal to 450 divided by [(FPG)2 ? (FPG X 3.5)] c. Quantitative insulin sensitivity check index (QUICKI)- QUICKI is equal to 1 divided by [log (fasting insulin microIU per mL) plus log (fasting plasma glucose mg per dL)] 4. Change in Lipid profile (assessment on Day 1, Day 90 & Day 180)- Quantification of TC, TG, LDL, HDL, VLDLTimepoint: 180 days;5. Change in anthropometric parameters (assessment on Day -1 to Day -7, Day 1, Day 90 & Day 180) - Body mass index (BMI), Waist circumference (WC), Waist-to-hip ratio (WHR), Body fat percentage (BFP). 6. Assess the peak plasma levels of Glucagon Like peptide-1 (GLP-1) at day 1 & day 180. 7. Change in Gut microbiome (assessment on Day 1 & Day 180) - Microbiota analysis of subjects from test & placebo arm (randomly selected 5 subjects from each arm on Day 1). 8. Q | — |
Countries
India
Contacts
Public ContactDr Mukul Maurya
Advanced Enzymes Technologies limited
Outcome results
None listed