Insulin resistance Nutritional, Metabolic, Endocrine Insulin resistance
Conditions
Interventions
Participants are randomized by health care zone to one of two groups.
Low-fructose diet intervention (LFDI) group: Participants are assigned to health centers in the western zone of T
Sponsors
Fundación Canaria de Investigación Sanitaria
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 29-66 years 2. BMI between 29 and 40.99 kg/m2
Exclusion criteria
Exclusion criteria: 1. Pregnancy (female participants only) 2. Behavioral eating disorders 3. Relevant gastrointestinal disease (ulcerating colitis, Crohn’s disease, celiac disease, digestive tract cancer) 4. Excessive alcohol consumption (>28 U or 280 g/week in men, > 17 U or 168 g/week in women 5. Severe cardiovascular disease 6. Diabetes, 7. Polycystic ovary disease 8. Treatment with any medication that could alter insulin sensitivity or body weight (corticosteroids, antipsychotics, antidepressants) 9. Pharmacological treatment for clinical or subclinical hypothyroidism 10. Hyperthyroidism 11. Depression 12. Psychosis 13. Microalbumin/creatinine ratio >100 mg/g or stage IIIB or higher chronic kidney disease (glomerular filtration rate < 45 mL/min) 14. Use of medication requiring frequent dose adjustments 15. Low intellectual or mental functioning that could interfere with the participant’s compliance with the recommendations 16. If the result of the glucose overload test is blood glucose = 200 mg/dL the participant is excluded if the physician opts to add medication or insulin to the dietary and physical exercise regime.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin resistance is estimated from fasting serum glucose (measured with enzymatic methods) and insulin concentrations (measured with a chemiluminescence immunoassay method) with a computer-based Homeostasis Model Assessment system (HOMA2-IR) at baseline, 24 and 48 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Body mass index is determined using weight and height measurements at baseline, 4, 8, 12, 20, 24 and 48 weeks 2. Waist circumference is determined using a nonstretchable measuring tape at baseline, 4, 8, 12, 20, 24 and 48 weeks 3. Total Cholesterol, HDL cholesterol and triglycerides are measured using enzymatic methods at baseline, 24 and 48 weeks. LDL cholesterol is calculated using the Friedewald formula | — |
Countries
Spain
Outcome results
None listed