EFFECTIVENESS OF A TRIPLE NUTRITIONAL INTERVENTION AND PHYSICAL IN PREDIABETIC PATIENRS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: A TRIPLE INTERVENTION NUTRITION AND PHYSICAL ACTIVITY.
- Who it may be relevant to
- Registry conditions: Diabetes. Basic parameters: 35 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
EFFECTIVENESS OF A TRIPLE NUTRITIONAL INTERVENTION AND PHYSICAL ACTIVITY FOR GLYCOSYLATED HB CONTROL IN PREDIABETICS: CLINICAL TRIAL
Overview
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 product A 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.
Primary outcome measures
- Glycated hemoglobin (HbA1c) [Time frame: At baseline, 3 and 6 months]
Secondary outcome measures (5)
- BMI (kg/cm2) [Time frame: At baseline, 3 and 6 months]
- Satisfaction of patients [Time frame: At 6 months]
- Physical exercise index [Time frame: At baseline, 3 and 6 months]
- Compliance with the triple dietary intervention [Time frame: At 3 and 6 months]
- Percentage of patients who reach normoglycemia (HbA1c < 5.7) [Time frame: At 3 and 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Spain · 1 center
- Antxon Apiñaniz — Vitoria-Gasteiz
Identifiers
NCT: NCT06820775 · PREDIABET01