| CTRI Number |
CTRI/2025/09/095077 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Does adding Fenofibrate to statin treatment improve nerve health compared to statin alone in people with diabetes and nerve damage |
|
Scientific Title of Study
|
Comparison of statin monotherapy versus statin plus fenofibrate combination therapy on nerve conduction parameters in diabetic peripheral neuropathy with dyslipidemia in a tertiary care hospital: a randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohit Raj Singh |
| Designation |
PGT General Medicine |
| Affiliation |
NH-Rabindranath Tagore International Institute of Cardiac Sciences |
| Address |
NH-Rabindranath Tagore International Institute of Cardiac Sciences, 124,Mukundapur,E.M.Bypass,Kolkata
Department of general medicine,RTIICS building 2nd floor,Room number 1209
Kolkata
WEST BENGAL
700099
India |
| Phone |
7890878814 |
| Fax |
|
| Email |
mohitsngh98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mainak Banerjee |
| Designation |
Consultant Endocrinologist |
| Affiliation |
NH-Rabindranath Tagore International Institute of Cardiac Sciences |
| Address |
NH-Rabindranath Tagore International Institute of Cardiac Sciences, 124,Mukundapur,E.M.Bypass,Kolkata
Department of Endocrinology,Executive Building ,Room number - 1
Kolkata
WEST BENGAL
700099
India |
| Phone |
9874116521 |
| Fax |
|
| Email |
drmainakbanerjee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mainak Banerjee |
| Designation |
Consultant Endocrinologist |
| Affiliation |
NH-Rabindranath Tagore International Institute of Cardiac Sciences |
| Address |
NH-Rabindranath Tagore International Institute of Cardiac Sciences, 124,Mukundapur,E.M.Bypass,Kolkata
Department Of Endocrinology,Executive Building,Room number - 1
Kolkata
WEST BENGAL
700099
India |
| Phone |
9874116521 |
| Fax |
|
| Email |
drmainakbanerjee@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana Health(NH)-Rabindranath Tagore International Institute of Cardiac Sciences.
124,Mukundapur,E.M.Bypass,Kolkata-700099 , West Bengal,India. |
|
|
Primary Sponsor
|
| Name |
Dr Mohit Raj Singh |
| Address |
Narayana Health(NH)-Rabindranath Tagore International Institute of Cardiac Sciences, 124,Mukundapur,E.M.Bypass,Kolkata-700099,West Bengal,India. |
| Type of Sponsor |
Other [SELF] |
|
|
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 Mohit Raj Singh |
Narayana Health(NH)-Rabindranath Tagore International Institute of Cardiac Sciences |
124,Mukundapur,E.M.Bypass,
Kolkata-700099,
Department of General Medicine , RTIICS Building,2nd Floor,Room Number-1209
Kolkata
WEST BENGAL |
7890878814
mohitsngh98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NHRTIICS ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fenofibrate |
Fenofibrate 160mg daily in addition to Standard of care(SOC) for 26 weeks |
| Comparator Agent |
Standard Of Care |
SOC mainly comprised of rosuvastatin 10mg,up-titrated to maintain LDL-C targets for 26 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age between 40 to 65 years old; established diagnosis of Type 2 Diabetes Mellitus according to the American Diabetes Association (ADA) criteria; diagnosis of Early Diabetic Peripheral Neuropathy (DPN) evidenced by the presence of sensory neuropathic symptoms (e.g., pain, paresthesia, numbness) in the lower extremities and an mTCNS score of 1 to 11, indicating minimal-to-moderate evidence of DPN; diabetic dyslipidemia defined as Triglycerides more than or equal to 150 mg/dL and HDL-C less than 40 mg/dL for men or less than 50 mg/dL for women; glycemic control with HbA1c less than or equal to 10%; and willingness and ability to provide written informed consent. |
|
| ExclusionCriteria |
| Details |
1) Presence of other known causes of peripheral neuropathy (e.g., vitamin B12 deficiency, alcohol abuse, chemotherapy-induced neuropathy, autoimmune neuropathy, radiculopathy); 2) a modified TCNS score more than 11, indicative of severe neuropathy; abnormal nerve conduction studies (NCS) suggestive of predominantly demyelinating neuropathy or other changes not consistent with typical DPN; 3) very high triglyceride levels mandating fenofibrate in the comparator arm (Triglyceride more than 1000 mg/dL or whenever deemed appropriate by the investigator); 4) an estimated glomerular filtration rate (eGFR) less than 30 mL per min per 1.73 m²; 5) previous history of myopathy or rhabdomyolysis; 6) use of medications known to affect nerve function (e.g., certain chemotherapeutic agents, amiodarone) or serum triglycerides (e.g., other fibrates, high-dose niacin, omega-3 fatty acids at high doses) within 3 months prior to screening; 7) uncontrolled hypothyroidism; 8) pregnancy or breastfeeding; 9) active cancer requiring treatment; 10) a history of major cardiovascular event (e.g., myocardial infarction, stroke) within the past 6 months; or any other condition that would interfere with the ability of participants to complete the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome measure is the change from baseline in Sural nerve conduction velocity (NCV) at 26 weeks, defined as the between-group difference in mean changes of meters per second (m/s). This objective measure will be assessed using standardised nerve conduction studies, ensuring consistent procedures are followed for all measurements. |
The primary outcome measure is the change from baseline in Sural nerve conduction velocity (NCV) at Baseline(Zero weeks ) and 26 weeks, defined as the between-group difference in mean changes of meters per second (m/s). This objective measure will be assessed using standardised nerve conduction studies, ensuring consistent procedures are followed for all measurements. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Change from baseline in peroneal NCV (in m/s) at 26 weeks, reflecting motor nerve fiber integrity. |
Baseline and 26 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/10/2025 |
| 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 Applicable |
| 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
|
This pragmatic randomised controlled trial is meticulously designed to
ascertain the effectiveness and safety of fenofibrate as an adjunct to
standard of care in improving nerve conduction parameters for adults with early
diabetic peripheral neuropathy and diabetic dyslipidemia. A core strength of
this trial lies in its rigorous methodology, including a prospective,
assessor-blind design, and the use of objective nerve conduction studies as
primary and key secondary outcomes, allowing for a precise evaluation of
intervention efficacy. The carefully defined inclusion and exclusion criteria,
coupled with the glycemic stabilisation run-in phase, aim to ensure a
relatively homogeneous study population, enhancing the internal validity of the
findings. The study’s focus on a specific, high-risk subgroup (early DPN with
dyslipidemia) addresses a critical unmet need for targeted interventions. |