Diabetes represents a substantial burden on health care systems. People with prediabetes IGT (impaired glucose tolerance) or IFG (impaired fasting glucose) are at high risk of developing diabetes, and up to 50% progress to diabetes within 5 years. OBJECTIVE: To evaluate the effectiveness of a triple intervention (physical activity and ordered healthy diet) to improve glycosylated hemoglobin control in prediabetic patients. MATERIAL AND METHODOLOGY: Randomized, open, controlled clinical trial with routine clinical practice (health advice for physical activity and healthy diet). Study population: obese or overweight patients of the OSI Araba aged 35-70 years who are in the contemplation stage. Response assessment: Primary variable: glycosylated hemoglobin; Secondary variables: Body Mass Index (BMI) (kg/cm2); blood pressure (mm Hg); satisfaction questionnaire score; physical exercise index (IPAQ) (METs). Statistical analysis: The analysis of the main variable (change in HbA1c at 6 months between both groups) will be assessed by analysis of covariance, ANCOVA, adjusting for baseline HbA1c. Sample size: 41 patients per arm (+30% to cover losses to follow-up).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
82
Intervention group: Health advice and triple intervention: 15 ml apple cider vinegar diluted in a glass of water before meals, order in the sequence of meals (sequence of food intake: first vegetables, second proteins, third fats and finally carbohydrates) and physical activity immediately after meals. Description of all interventions: Patients in both groups: all patients will receive health advice on sports practice from the WHO, Osakidetza and the Basque Government.
Antxon Apiñaniz
Vitoria-Gasteiz, Alava, Spain
Glycated hemoglobin (HbA1c)
Glycated hemoglobin (HbA1c)
Time frame: At baseline, 3 and 6 months
BMI (kg/cm2)
BMI (kg/cm2)
Time frame: At baseline, 3 and 6 months
Satisfaction of patients
Score in the satisfaction questionnaire
Time frame: At 6 months
Physical exercise index
Physical exercise index (IPAQ)
Time frame: At baseline, 3 and 6 months
Compliance with the triple dietary intervention
Compliance with the triple dietary intervention
Time frame: At 3 and 6 months
Percentage of patients who reach normoglycemia (HbA1c < 5.7)
Prcentage of patients who reach normoglycemia (HbA1c \< 5.7).
Time frame: At 3 and 6 months
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