Home » Trials » SLCTR/2025/010
Impact of Personalized Medical Nutrition Therapy on HbA1c, Body Weight, and Quality of Life in Patients with Type 2 Diabetes: A Randomized Controlled Trial from Sri Lanka
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SLCTR Registration Number
SLCTR/2025/010
Date of Registration
The date of last modification
Mar 21, 2025
Scientific Title of Trial
Impact of Personalized Medical Nutrition Therapy on HbA1c, Body Weight, and Quality of Life in Patients with Type 2 Diabetes: A Randomized Controlled Trial from Sri Lanka
Public Title of Trial
A randomized controlled trial of patients with type 2 diabetes comparing the effect of medical nutrition therapy to standard care in improving blood glucose control, weight and well being
Disease or Health Condition(s) Studied
Type 2 Diabetes
Scientific Acronym
PMNT-T2D SL RCT (Personalized Medical Nutrition Therapy in Type 2 Diabetes Sri Lanka Randomized Controlled Trial)
Public Acronym
PNT-Diabetes SL ( Personalized Medical Nutrition Therapy for Diabetes in Sri Lanka )
Brief title
Personalised medical nutrition therapy in diabetes control
Universal Trial Number
U1111-1319-5264
Any other number(s) assigned to the trial and issuing authority
P/162/12/2024 - Ethics Review Committee, Faculty of Medicine, University of Kelaniya
What is the research question being addressed?
What is the impact of Personalized Medical Nutrition Therapy on HbA1c, body weight, and quality of life, compared to standard care, in patients with type 2 diabetes in Sri Lanka?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
Study setting - The study will be carried out at General Medical Clinics of the University Medical Unit at Colombo North Teaching Hospital, Ragama.
Sampling Procedure - Patients who fulfil inclusion criteria will be assigned to intervention and control groups randomly, as every 3rd (Intervention) and 6th patient (Control).
Participants will be randomly assigned to either the intervention group receiving personalized MNT or a control group receiving standard clinic care.
The intervention will consist of: -Three individual sessions of MNT at enrolment, and at 1, 3, and 5 months conducted by a consultant nutritionist. - Customized meal plans based on individual preferences and cultural food practices will be provided to the intervention group and support and assessment via WhatsApp at second and fourth months will also be provided.
Standard therapy includes advice from the clinic doctor on diet, exercise and medication adherence and a diet sheet detailing the ideal diet that a patient with diabetes should be taking. This diet sheet is prepared by the hospital Nutrition Unit and is given to all patients diagnosed with diabetes in the clinics.
Inclusion criteria
• Adult males and females aged 30-65 years • Diagnosed with T2DM (HbA1c greater than or equal to 7%) for at least 2 years
Exclusion criteria
• Patients with severe comorbidities such as advanced cardiac failure, advanced liver disease, end-stage renal disease, and chronic respiratory failure • Patients diagnosed with a malignancy • Patients with advanced complications of Type 2 diabetes mellitus (DM) • Patients currently receiving intensive dietary counseling • Type 1 DM • Secondary DM
Primary outcome(s)
|
1.
Change in HbA1c levels from baseline to 6 months. |
[ Phase 1 ( baseline - week 0) Phase 2 (after 6 months) ] |
Secondary outcome(s)
|
1.
Change in body weight |
[ Phase 1 ( baseline - week 0) Phase 2 (after 6 months) ] |
|
2.
Quality of life assessed using the WHO Quality of Life brief Scale |
[ Phase 1 ( baseline - week 0) Phase 2 (after 6 months) ] |
Target number/sample size
120 (60 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2025-04-01
Anticipated end date
2025-09-30
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Investigator funded
Regulatory approvals
N/A
Status
Approved
Date of Approval
2025-01-16
Approval number
P/162/12/2024
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya. |
| Institutional Address: | PO Box 06, Thalagolla Road, Ragama, Sri Lanka. |
| Telephone: | 011-2961267 |
| Email: | ercmed@kln.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Shamila Thivanshi De Silva
Professor in Medicine and Specialist Physician in Internal Medicine
Department of Medicine, Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka
+9411 2961119
+94 773 601490
shamiladp@kln.ac.lk
https://medicine.kln.ac.lk/index.php/dr-s-t-de-silva.html
Contact Person for Public Queries
Shamila Thivanshi De Silva
Professor in Medicine and Specialist Physician in Internal Medicine
Department of Medicine, Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka
+9411 2961119
+94 773 601490
shamiladp@kln.ac.lk
https://medicine.kln.ac.lk/index.php/dr-s-t-de-silva.html
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
