Prevention of the development of diabetes in people with prediabetes Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
Among the 381 individuals initially screened, 105 were diagnosed with prediabetes and 90 eventually met the inclusion criteria and agreed to participate. They were randomly assigned by computer code t
n = 45) or nothing (control group
n = 45). Both groups were advised to adopt specific lifestyle changes according to the ADA recommendations for the prevention of diabetes, namely at least 150 min per week of moderate-intensity aerobi
Sponsors
Aristotle University of Thessaloniki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women with prediabetes aged 60 years and older 2. Listed on the registry of the Open Care Center for the Elderly of the Municipality of Eastern Thessaloniki, Greece. 3. Prediabetes diagnosed according to the criteria of the American Diabetes Association (ADA), either by impaired fasting plasma glucose (IFG) [fasting plasma glucose (FPG): 100–125 mg/dl] or impaired glucose tolerance (IGT) [2-h plasma glucose in 75 g oral glucose tolerance (OGTT): 140–199 mg/dl] or by values of glycated hemoglobin (HbA1c) between 5.7% (39 mmol/mol) and 6.4% (46 mmol/mol)
Exclusion criteria
Exclusion criteria: 1. Pre-existing diabetes mellitus 2. Normal glucose levels 3. Any medical conditions that could potentially affect the outcomes of the study or increase the risk of complications following vitamin D supplementation (nephrolithiasis, hypercalcemia, hyperparathyroidism, sarcoidosis, and chronic renal disease [stages 3 to 5 / estimated glomerular filtration rate <45 ml/min/1.73m²]) 4. Malignancies 5. Inflammatory or rheumatic diseases 6. Psychiatric conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Fasting glucose measured using the Cobas INTEGRA clinical chemistry system at 3, 6, and 12 months after the start of vitamin D supplementation 2. Glycated hemoglobin values measured using the ADAMS HA-8160 high-performance liquid chromatography method at 3, 6, and 12 months after the start of vitamin D supplementation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of total participants who progressed to diabetes or returned to normoglycemia based on fasting glucose and 2 h glucose in 75 g oral glucose tolerance test (OGTT) values at 12 months after the start of vitamin D supplementation 2. Anxiety measured with the State-Trait Anxiety Inventory tool at 6 and 12 months after the start of vitamin D supplementation 3. Depression measured with the Patient Health Questionnaire-9 tool at 6 and 12 months after the start of vitamin D supplementation | — |
Countries
Greece
Outcome results
None listed