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Clinical Trials in Spain / NCT06820775
Starting soon Not applicable

EFFECTIVENESS OF A TRIPLE NUTRITIONAL INTERVENTION AND PHYSICAL IN PREDIABETIC PATIENRS

NCT06820775 · tracked via the Priya Life Science Spain tracker
Sponsor
Bioaraba Health Research Institute
Phase
Not applicable
Started
2025-02-02
Last updated
2025-02-11

Condition(s) studied

Diabetes

Investigational drug(s) / intervention(s)

A TRIPLE INTERVENTION NUTRITION AND PHYSICAL ACTIVITY

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.

Study 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).

Eligibility

Sex
ALL
Min age
35 Years
Max age
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Antxon Apiñaniz Vitoria-Gasteiz Alava

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06820775 on ClinicalTrials.gov ↗ ← All trials in Spain