| CTRI Number |
CTRI/2023/11/059866 [Registered on: 15/11/2023] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nutritional beverage] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Glycemic effect of diabetes specific nutrition supplement |
|
Scientific Title of Study
|
Effect of low glycemic index Diabetes Specific Nutritional Supplement on Glycemic Control in Indian Adults with Type 2 Diabetes Mellitus: A Randomized, Controlled Trial (PRIDE II) |
| Trial Acronym |
PRIDE II |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V Mohan |
| Designation |
President & Chief of Diabetes Research |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of foods, nutrition and dietetics research, 6B Conron Smith Road, Gopalapuram
Chennai
TAMIL NADU
600086
India |
| Phone |
9840014480 |
| Fax |
|
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Mohan |
| Designation |
President & Chief of Diabetes Research |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of foods, nutrition and dietetics research, 6B Conron Smith Road, Gopalapuram
Chennai
TAMIL NADU
600086
India |
| Phone |
9840014480 |
| Fax |
|
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Sudha Vasudevan |
| Designation |
Senior Scientist and Head- Department of Foods, Nutrition & Dietetics Research |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of foods, nutrition and dietetics research,6B Conron Smith Road, Gopalapuram
Chennai
TAMIL NADU
600086
India |
| Phone |
9840014480 |
| Fax |
|
| Email |
s2r_7@mdrf.in |
|
|
Source of Monetary or Material Support
|
| Sun Pharmaceutical Industries Ltd
SPARC, Tandalja, Baroda – 390 012, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Madras Diabetes Research Foundation |
| Address |
No 6B Conran smith Road, Gopalapuram Chennai 600086 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sun Pharmaceutical Industries Ltd |
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai - 400 063 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohan V |
Madras Diabetes Research Foundation |
Department of Foods
Nutrition Dietetics
Research 6B Conron
Smith Road
Gopalapuram
Chennai
TAMIL NADU |
044439688888
drmohans@diabetes.ind.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Madras Diabetes Research Foundation Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Control Arm (Group B): Standard of Care (Diabetes treatment along with Life Style modification and Diet as per diet prescription) |
| Intervention |
Test group |
Intervention/Test Arm (Group A): Prohance-D (Diabetes Specific Nutritional Supplement) + Standard of Care (Diabetes treatment along with Life Style modification and Diet as per diet prescription and calories adjusted with IP’s calories) |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age: 30- 65 years old male and non-pregnant females
Diagnosis of Type 2 Diabetes Mellitus for at least 1 year; treated with stable dose of oral anti-diabetic drugs (drugs permitted: metformin, sulfonylureas, Thiazolidinediones, DPP-IV inhibitors, AGIs) for at least 3 months before screening.
Participants with HbA1c from 8 to 11%
Body mass index (BMI) ≥25 kg/m2
Participant willing to provide informed consent and willing to comply with study procedures
|
|
| ExclusionCriteria |
| Details |
Type 1 Diabetes Mellitus participants.
Type 2 Diabetes Mellitus participants on insulin, GLP-1 agonists and/or SGLT2 inhibitors.
Allergy to one or more components of the investigational product or history of food allergies
Participant receiving any diabetes specific nutritional food supplement apart from multivitamin/ mineral supplements (Ca/Vit D supplements and B complex syrups) within 15 days prior to study start.
Participant taking any herbal/ ayurvedic/ alternative medicine preparations that could profoundly affect blood glucose.
Females who are nursing / pregnant / are of child - bearing potential and not practicing an acceptable method of birth control / or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
Participant has evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease, which in the opinion of the investigator, can adversely affect study outcome/s.
Participant with active infection in past 30 days.
Participant with history of acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) infection.
Participant has a history of any episode(s) of severe hypoglycemia (requiring third party assistance), disabling diabetic neuropathy including autonomic neuropathy, gastroparesis or lower limb ulceration or amputation or evidence or history of diabetic complications with significant end organ damage.
Participant has a history of illicit drug or alcohol abuse within last 1 year.
Participants on therapy with the following drugs will not be permitted to participate in the trial: DRUGS CAUSING HYPERGLYCEMIA (Thiazides, Glucocorticoids, Diazoxide, Glucagon, Phenytoin, Tacrolimus, Niacin, L-asparaginase, Cyclosporine, Protease inhibitors) and DRUGS CAUSING HYPOGLYCEMIA (Quinine, Insulin, Ethanol, Octreotide, Salicylates-late in overdose), currently or within past 3 months from the time of screening
Participants on any pharmacological therapy of modern or alternative medicine for management of obesity in past 6 months.
Participants with history of bariatric surgery.
Participant has any major or minor surgery within 30 days prior to screening.
Participant has a history or confirmed diagnosis of malignancy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in incremental Area Under the Curve (iAUC) on Ambulatory Glucose Profile using Continuous Glucose monitoring from baseline to 12 weeks |
2 time points baseline and end of 12 weeks study period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in CGM variables such as Mean amplitude of Glycemic excursions (MAGE),Time in Range (TIR),Time above range (TAR),Time below range (TBR),Mean blood glucose |
2 time points baseline and end of 12 weeks study period. |
| Mean change in HbA1C levels |
2 time points baseline and end of 12 weeks study period. |
| Mean changes in fasting blood glucose levels |
4 time points baseline,4,8 and end of 12 weeks study period. |
| Mean changes in post prandial blood glucose levels |
2 time points baseline and end of 12 weeks study period. |
| Mean changes in anthropometric measurement (weight, BMI & waist circumference) |
Anthropometric measurements will also be measured monthly once
Assessed using 24 hr dietary recall 3 times at baseline and twice a month during the intervention period |
| Mean changes in lipid profile [total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides] |
2 time points baseline and end of 12 weeks study period. |
| Mean change in plasma fatty acids level in a sub sample of 60 participants (30 in each arm) |
2 time points baseline and end of 12 weeks study period. |
| Change in participant-reported outcomes on satiety using satiety rating scale |
4 time points baseline,4,8 and end of 12 weeks study period. |
| Proportion of participants with adverse events and serious adverse events |
7 time points start from day 1 and every week of the study |
|
Target Sample Size
Modification(s)
|
Total Sample Size="172"
Sample Size from India="172"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/11/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Randomized parallel arm study with 172 adults with type 2 diabetes. This is an open label, prospective, randomized controlled study. Participants fulfilling the eligibility criteria will be enrolled in the study. Participants will be screened and all the eligible participants will be put on 4 days run-in period of test product (Prohance-D) to check compliance. This will be followed by 10 days washout period. Participants will then be randomized (computer generated random numbers) into either of following 2 arms: · Intervention/Test Arm (Group A): Prohance-D (Diabetes Specific Nutritional Supplement) + Standard of Care (Diabetes treatment along with Life Style modification and Diet as per diet prescription and calories adjusted with IP’s calories) · Control Arm (Group B): Standard of Care (Diabetes treatment along with Life Style modification and Diet as per diet prescription) All the participants will be instructed not to make any major modifications in their routine diet and physical activity and refrain from feasting and fasting during the study period
Anthropometric, clinical, biochemical, dietary and physical activity levels will be assessed at periodic time intervals. |