Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine
Conditions
Interventions
This is a two-phase (weight-loss diet through low-carb and med diets, and weight-maintenance phase using a customized mobile app) parallel-group randomized controlled trial conducted among adults with
aged 18–65 years, BMI =25 kg/m², disease duration =6 years, treated exclusively with oral anti-diabetic medications) will be randomly allocated to one of two intervention arms.
Arm 1: Moderately low-
Sponsors
Maastricht University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18–65 years with T2DM 2. BMI =25 kg/m² 3. Exclusively on oral anti-diabetic medications 4. Disease duration of 6 years or less
Exclusion criteria
Exclusion criteria: 1. Renal failure 2. Cancer 3. Mental problems 4. Insulin use 5. Diabetes for more than 6 years
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline and every 3 months: 1. Lipid profile (HDL, LDL, triglycerides, total cholesterol) and C-reactive protein (CRP) as an inflammatory marker, measured using blood tests 2. Diabetes knowledge assessed using diabetes knowledge questionnaire 3. Physical activity assessed using the International Physical Activity Questionnaire (IPAQ) 4. Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI) 5. Psychological stress assessed using the Perceived Stress Scale (PSS) 6. Medication adherence assessed using the Morisky–Green–Levine (MGL) scale 7. Dietary intake and adherence assessed using 24-hour dietary recalls at each dietetic visit and the Mediterranean Diet Adherence Scale at baseline, after 3 months, and at the end of the intervention | — |
Countries
Lebanon
Contacts
Public ContactJanot Ayoub
Outcome results
None listed