Diabetes Remission Trial Protocol for Mediterranean and Low-Carbohydrate Diets

A clinical trial protocol details a 12-month randomized controlled trial comparing low-calorie Mediterranean and low-carbohydrate diets for diabetes remission in 50 adults with type 2 diabetes in Northern Lebanon. The protocol, authored by Janot J. Ayoub and published on figshare, was last updated in April 2026. It describes a two-phase study with a 6-month weight loss intervention and a 6-month maintenance phase supported by a mobile health application.

Use Cases

• Analyze the Intervention Mapping framework steps used to design the culturally tailored behavioral intervention for diabetes remission.
• Compare the primary outcome (HbA1c < 6.5% at 6 months) and secondary outcomes (weight, lipid profile, sleep quality) between the two dietary arms.
• Review the study's inclusion criteria (age 18-65, diabetes duration ≤6 years, on oral medications) for designing similar trials.
• Examine the mobile health application component described for the 6-month maintenance phase to inform digital health support strategies.

Strengths

• Protocol is registered with a clinical trials registry (ISRCTN99204002), ensuring transparency and methodological rigor.
• Clearly defines primary and secondary outcomes, including HbA1c, weight, body composition, lipid profile, and psychological measures.

Limitations

• The dataset is a protocol document (34.5 KB DOCX file), not a results dataset, containing no actual patient measurements or trial outcomes.
• The planned sample size is 50 participants, which is small for generalizing findings about diabetes remission efficacy.

Provenance

Source

figshare, authored by Janot J. Ayoub.

Collection Method

Designed as a research protocol for a randomized controlled trial.

Time Range

The protocol describes a planned 12-month trial follow-up duration.

Freshness

Protocol was last updated in April 2026, indicating it is a forward-looking document for a planned or ongoing trial.

Geography

Primary medical centers in Northern Lebanon.