Diabetes
Conditions
Keywords
DIABETES MELLITUS
Brief summary
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).
Interventions
COMBINATION_PRODUCTA TRIPLE INTERVENTION NUTRITION AND PHYSICAL ACTIVITY
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.
Sponsors
Bioaraba Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Prediabetics with glycosylated hemoglobin (HbA1c) 5.7-6.4 (24, 38) and signing informed consent. \-
Exclusion criteria
Presence of physical or psychological illnesses that prevent physical activity; participation in another research project; pregnancy or breastfeeding; patients undergoing dietary or pharmacological treatment for weight loss; history of myocardial infarction or stroke; diabetic, taking drugs for diabetes mellitus and taking drugs such as Gliflozin for pathologies other than diabetes mellitus. of physical or psychological illnesses that prevent physical activity; participation in another research project; pregnancy or breastfeeding; patients undergoing dietary or pharmacological treatment for weight loss; history of myocardial infarction or stroke; diabetic, taking drugs for diabetes mellitus and taking drugs such as Gliflozin for pathologies other than diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycated hemoglobin (HbA1c) | At baseline, 3 and 6 months | Glycated hemoglobin (HbA1c) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI (kg/cm2) | At baseline, 3 and 6 months | BMI (kg/cm2) |
| Satisfaction of patients | At 6 months | Score in the satisfaction questionnaire |
| Physical exercise index | At baseline, 3 and 6 months | Physical exercise index (IPAQ) |
| Compliance with the triple dietary intervention | At 3 and 6 months | Compliance with the triple dietary intervention |
| Percentage of patients who reach normoglycemia (HbA1c < 5.7) | At 3 and 6 months | Prcentage of patients who reach normoglycemia (HbA1c \< 5.7). |
Countries
Spain
Contacts
Primary ContactANTXON GENERAL PRACTITIONNER
Outcome results
None listed