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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2025/010
Enrollment
Unknown
Registered
2025-03-22
Start date
2025-04-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Interventions

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

Sponsors

Faculty of Medicine, University of Kelaniya
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Change in HbA1c levels from baseline to 6 months. [Phase 1 ( baseline - week 0) Phase 2 (after 6 months)]

Secondary

MeasureTime frame
Change in body weight [Phase 1 ( baseline - week 0) Phase 2 (after 6 months)] Quality of life assessed using the WHO Quality of Life brief Scale [Phase 1 ( baseline - week 0) Phase 2 (after 6 months)]

Countries

Sri Lanka

Contacts

Public ContactShamila Thivanshi De Silva

Professor in Medicine and Specialist Physician in Internal Medicine

shamiladp@kln.ac.lk+9411 2961119

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 10, 2026