Obesity Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
Participants are randomly allocated to one of two groups using a computer-generated sequence of random numbers.
Intervention group: Participants take up a Mediterranean diet for two years, which is b
Sponsors
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 35-55 years 2. Metabolically healthy obese (MHO)* 3. BMI between 30-45 kg/m2 *A participant is considered to have MHO status when meeting =1 of these four metabolic syndrome criteria: fasting plasma glucose =100 mg/dL, blood pressure =135/85 mmHg (or use of blood pressure-lowering agents), HDL-cholesterol =50 mg/dL, and triglycerides =150 mg/dL (or use of lipid-lowering therapies).
Exclusion criteria
Exclusion criteria: 1. Diabetes or impaired glucose tolerance 2. Hypertension 3. Pregnancy or planning to become pregnant during the study 4. Cardiovascular disease 5. Severe systemic disease (advanced organ failure, dementia, cancer) 6. Immobilized individuals 7. Alcohol or drug abuse 8. Severe psychiatric illness 9. Patients who self-initiated a program of physical activity or started a diet in the past three months 10. Weight loss =5 kg in the last 6 months of unknown cause
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Type 2 diabetes and/or prediabetes incidence is determined by measuring: 1. Fasting plasma glucose levels at baseline, 3, 6, 12, 18 and 24 months 2. Oral glucose tolerance testat baseline, 12 and 24 months 3. Glycated hemoglobin (HbA1c) at baseline, 3, 6, 12, 18 and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anthropometric variables are measured at baseline, 3, 6, 12, 18 and 24 months for the intervention group and at baseline, 12, 18 and 24 months in the control group. 1.1. Weight measured in kg on a scale 1.2. Waist circumfrence is measured in cm 1.3. BMI is calculated as the ratio between weight and height (kg/m2) 1.4. Blood pressure is measured using a validated automatic sphygmomanometer (OMRON M4-I) when the participant is in a sitting position. 2. Insulin resistance is calculated using the HOMA-IR index and proinsulin/insulin ratio at baseline, 12, 18 and 24 months 3. Serum lipid profile (HDL-cholesterol, LDL-cholesterol, Triglycerides) is measured using commercial equipment (Dimension®, Dade Behring, Germany) at baseline, 12, 18 and 24 months 4. Inflammatory parameters (leucocytes, fibrinogen, hs-CRP, IL-6, TNF-a) are measured using an Enzyme-Linked ImmunoSorbent Assay at baseline, 12, 18 and 24 months 5. Metabolic hormone (adiponectin and resistin) levels are measured using an Enzyme-Linked ImmunoSorbent Assay at baseline, 12, 18 and 24 months 6. Liver function is measured through serum liver function tests (AST, ALT, GGT) and Fatty Liver Index (FLI) at baseline, 12, 18 and 24 months | — |
Countries
Spain
Outcome results
None listed