Home » Trials » SLCTR/2025/013
Effects of sodium glucose co-transporter-2 (SGLT2) inhibitor, empagliflozin, compared to dipeptidyl peptidase-4 inhibitor, sitagliptin on functions of the autonomic nervous system, peripheral nerves and muscles of the patients with type 2 diabetes attending National Hospital Galle and laboratory evaluation of the quality control parameters of commercially available SGLT2 inhibitor tablets in Galle, Sri Lanka.
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SLCTR Registration Number
SLCTR/2025/013
Date of Registration
The date of last modification
Apr 04, 2025
Scientific Title of Trial
Effects of sodium glucose co-transporter-2 (SGLT2) inhibitor, empagliflozin, compared to dipeptidyl peptidase-4 inhibitor, sitagliptin on functions of the autonomic nervous system, peripheral nerves and muscles of the patients with type 2 diabetes attending National Hospital Galle and laboratory evaluation of the quality control parameters of commercially available SGLT2 inhibitor tablets in Galle, Sri Lanka.
Public Title of Trial
The effect of SGLT-2 inhibitor, empagliflozin, a new diabetes medication, over sitagliptin on nerve and muscle health in patients with type 2 diabetes
Disease or Health Condition(s) Studied
Type 2 Diabetes
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1315-2858
Any other number(s) assigned to the trial and issuing authority
2024/P/082: ERC, Faculty of Medicine, Ruhuna
What is the research question being addressed?
What are the effects of sodium glucose co-transporter-2 (SGLT2) inhibitor, empagliflozin, compared to dipeptidyl peptidase-4 (DPP-4) inhibitor, sitagliptin on functions of the autonomic nervous system, peripheral nerves and muscles of the patients with type 2 diabetes attending National Hospital Galle?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Investigators
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
Study Setting: National Hospital, Galle, Sri Lanka Participants meeting the inclusion /exclusion criterial will be randomly allocated to two arms. Sealed opaque envelopes will be used for allocation concealment.
The intervention arm will receive empagliflozin 10mg to be taken orally, once daily (in the morning) for 6 months. The usual dose of biguanide and sulfonylurea will be continued, with dosage titrated by treating clinicians.
The control arm will continue the standard treatment of biguanide, sulfonylurea and sitagliptin for 6 months with dosage titrated by treating clinicians.
Single blinding will be achieved as follows: envelopes with assigned group will be prepared by a technical officer who is not involving the research study. The sealed envelops will be handed over to the consultant endocrinologist. The participant will be allowed to choose one envelop from the envelop collection and the consultant will change/continue the treatment according to the group which the patient selected. A record of allocation of the patient to the group (interventional/control) will be kept with the consultant endocrinologist until the data collection procedure ends. The record will be collected by the principal investigator for analysis.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Heart rate variability and Valsalva maneuver – Time and frequency domain of heart rate variability will be measured (LF and HF power ms2 and LF/HF ratio % and sympathetic/parasympathetic dominance). The ADInstrument machine and software will be used to measure heart rate variability. Valsalva maneuver will be assessed using FUUDA DENSHI- ECG/PHONO system FD-31P machine. The heart rate (baseline, during Valsalva and post procedure) will be measured. |
[ Baseline, at the end of 1 month, at the end of 3 months and at the end of 6 months. ] |
|
2.
Hand grip strength test measured using a LAFAYETTE Hand Dynamometer, previously calibrated, with a resolution of 2 kg, following the procedures adopted by the American Society of Hand Therapists. The grip strength average (in newton) will be measured. |
[ Baseline, at the end of 1 month, at the end of 3 months and at the end of 6 months. ] |
|
3.
Nerve conduction study of posterior tibial and sural nerve of lower limb assessed using NIHON KOHDEN Neuropack machine. The velocity and amplitude of both motor and sensory nerves will be measured. p value <0.05 calculated using Repeated Measures of ANOVA will be taken as statistically significant. |
[ Baseline, at the end of 1 month, at the end of 3 months and at the end of 6 months. ] |
|
4.
Lung function test using the COSMED Pony FX lung function machine. The data will be analysed using COSMED software. Improvement of >10% in FVC, FEV1 and PEFR after treatment will be considered as significant. |
[ Baseline, at the end of 1 month, at the end of 3 months and at the end of 6 months. ] |
Secondary outcome(s)
|
1.
None |
[] |
Target number/sample size
80 (40 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2025-05-01
Anticipated end date
2027-03-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2025-02-25
Approval number
2024/P/082(05.12.2024)
Details of Ethics Review Committee
| Name: | Ethics Review Committee |
| Institutional Address: | Faculty of Medicine, University of Ruhuna, Galle, Sri Lanka. |
| Telephone: | 091 2234801/803 Ext:161 |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Dr. M.A.L.D. Malwatta
Lecturer (probationary)
Department of Physiology, Faculty of Medicine, University of Ruhuna, Galle.
091 2234801
0717172473
dhananjanee@med.ruh.ac.lk
https://www.medi.ruh.ac.lk/physiology/staff/
Contact Person for Public Queries
Senior Professor Sampath Gunawardena
Chair Professor of Physiology
Department of Physiology, Faculty of Medicine, University of Ruhuna, Galle.
091 2234801
sampathgu@yahoo.com
https://www.medi.ruh.ac.lk/physiology/staff/
Primary study sponsor/organization
Department of Physiology
Faculty of Medicine, University of Ruhuna,
Galle, Sri Lanka
Tel": (+94) 091 2246871
Fax: (+94) 091 2222314 (General)
headphysiology@med.ruh.ac.lk
https://www.medi.ruh.ac.lk/physiology/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
