| CTRI Number |
CTRI/2024/07/070146 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study of nutritional formulations in prediabetes and type 2 diabetes mellitus. |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled clinical trial to assess the safety and efficacy of nutritional formulations in prediabetes and type 2 diabetes mellitus (T2DM). |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| LS/24-25/002 Version 1.00 dated 1 June 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amol Gothwad |
| Designation |
Principal Investigator |
| Affiliation |
Lokmanya Medical Research Centre and Hospital |
| Address |
Fourth floor OPD 401 314 B Telco Road Chinchwad
Pune
MAHARASHTRA
411033
India |
| Phone |
9766400243 |
| Fax |
- |
| Email |
amolgothwad01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishnavi Patil |
| Designation |
Project Coordinator |
| Affiliation |
Life Synergy |
| Address |
Office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan
nagar, Baner
Pune
MAHARASHTRA
411045
India |
| Phone |
9834585994 |
| Fax |
- |
| Email |
vaishnavilifesynergy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishnavi Patil |
| Designation |
Project Coordinator |
| Affiliation |
Life Synergy |
| Address |
Office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan
nagar, Baner
MAHARASHTRA
411045
India |
| Phone |
9834585994 |
| Fax |
- |
| Email |
vaishnavilifesynergy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Life Synergy office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan nagar, Baner,
Pune 411045, Maharashtra. |
|
|
Primary Sponsor
|
| Name |
Life Synergy |
| Address |
Office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan nagar, Baner, Pune 411045, Maharashtra |
| Type of Sponsor |
Other [Nutraceutical product promoter] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amol Gothwad |
Lokmanya Medical Research Centre and Hospital |
Fourth Floor OPD 401 314 B Telco Road Chinchwad
Pune
MAHARASHTRA |
9766400243
-
amolgothwad01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lokmanya Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E139||Other specified diabetes mellituswithout complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A (Diabetes type 2): LSGC01 capsule + Oral hypoglycemic agents (OHA) |
Twice a day for 90 days. |
| Comparator Agent |
Group B (Diabetes type 2): Placebo + Oral hypoglycemic agents (OHA) |
Twice a day for 90 days. |
| Intervention |
Group C (Prediabetes): LSGC01 Capsule |
Twice a day for 90 days. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and female participants between age 30-65 years (both inclusive); 2.Participants with a BMI of more than 28 and less than 35 kg/m2; 3.Participants with or without deranged lipid profile; For diabetic subjects 1.Participants receiving oral hypoglycemic agents (OHA) biguanides and sulfonylureas (only combination)Newly diagnosed participants who are eligible for inclusion may begin the trial with investigational product monotherapy. In the event of poor glycemic control, or safety concerns, the investigator may initiate standard-of-care treatment for type 2 diabetes mellitus; 2.Glycated haemoglobin (HbA1c) greater than 6.5% and less than 8% (both inclusive); 3.Fasting Plasma Glucose (FPG) greater than 130 mg/dL and less than 250 mg/dL (both inclusive); 4.Participants willing to comply with the study procedure and sign written informed consent; For pre-diabetic subjects 1.Participants with Hemoglobin A1c (HbA1c) greater than or equal to 5.7 % and less than or equal to 6.4%; 2.Participants with Fasting Plasma Glucose (FPG) between 100-125 mg/dl (both inclusive), post meal plasma glucose value between 140-199 mg/dl (both inclusive); 3.IDRS (Indian Diabetics Risk score) less than or equal to 60. |
|
| ExclusionCriteria |
| Details |
1.Participants with concurrent serious hepatic dysfunction (defined as AST and or ALT more than 3 times of the upper normal limit) or renal dysfunction (defined as S. creatinine more than 1.4 mg per dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease,
2.Participants suffering from major systemic illness necessitating long term drug treatment including but not limited to hematologic condition (eg., hemolytic anemias, sickle cell anemia), acute myocardial infarction, unstable angina, uncontrolled hypertension, congestive heart failure (class 3 or class 4 NYHA), or cerebrovascular accident, psychiatric or neurological disorder, autoimmune condition, received chronic (more than 14 days) therapy with systemic glucocorticoids (excluding topical, intraocular, intranasal, intra articular, or inhaled preparations) within six months prior to enrollment,
3.Smokers,Alcoholics and or drug abusers,
4.Participants with evidence or history of malignancy,
5.Involvement in any other clinical trial requiring drug therapy,
6.Pregnant or lactating women or women of fertile age not using effective contraception,
7.Any condition that could, in the opinion of the investigator, preclude the participants ability to complete the study or that may confound study outcomes.
For diabetic subjects
1.Type 1 diabetes,
2.Receiving antidiabetic drugs except for those specified in the inclusion criteria including Insulin treatment,
For pre-diabetic subjects
1.Participants with type 1 or type 2 diabetes mellitus (T2DM), gestational diabetes (GDM), or secondary diabetes,
2.Participants with any other co-morbidity,
3.Participants treatment with a glucose lowering or weight loss agent (s) within 90 days before screening.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Changes in Glycemic profile by assessing
a) Fasting, and post-meal plasma glucose levels from screening to the end of the study and
b) HbA1c levels
2.Changes in Insulin resistance by assessing Fasting insulin, HOMA-IR score |
From screening to end of the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Changes in lipid metabolism by assessing cholesterol, LDL, HDL, Triglycerides etc.
2.Changes in Metabolic Syndrome Severity Z Score.
3.Changes in anthropometric parameters like body weight, BMI, and waist circumference.
4.Changes in diabetes-related quality of life score assessed by DQOL questionnaire score to assess quality of life.
5.Changes in oxidative stress markers like serum SOD and MDA.
6.Changes in inflammatory markers like serum TNF, IL-6, SIRT1, SIRT 6, and CRP. |
From screening to end of the study. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Prediabetes and T2DM is a chronic metabolic disorder characterized by insulin resistance and hyperglycemia, leading to various complications affecting multiple organ systems. Despite the availability of OHAs, achieving and maintaining glycemic control in T2DM patients remains a challenge. Therefore, there is a continuous need for nutritional approaches that can effectively manage Prediabetes and T2DM while minimizing adverse effects and improving patients quality of life. This randomized, double blind, placebo controlled, parallel arm clinical trial aims to address this gap in knowledge by evaluating the safety and efficacy of nutritional formulation in Prediabetes and T2DM patients. The study incorporates a wide range of outcome measures, including glycemic profile, insulin resistance, lipid metabolism, metabolic syndrome severity, anthropometric parameters, diabetes-related quality of life and safety assessment. By examining multiple endpoints, the study provides a holistic evaluation of nutritional formulations impact on various aspects of Prediabetes and T2DM management.
|