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NCT Number: NCT06820775

EFFECTIVENESS OF A TRIPLE NUTRITIONAL INTERVENTION AND PHYSICAL IN PREDIABETIC PATIENRS

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).

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antxon Apiñaniz

Vitoria-Gasteiz, Alava, Spain

Location contact

ANTXON APIÑANIZ

CONTACT

945207935

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Prediabetics with glycosylated hemoglobin (HbA1c) 5.7-6.4 (24, 38) and signing informed consent.

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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.

Treatment and study plan

A TRIPLE INTERVENTION NUTRITION AND PHYSICAL ACTIVITY

Combination Product

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 outcomes

  1. Glycated hemoglobin (HbA1c)

    Time frame: At baseline, 3 and 6 months

    Glycated hemoglobin (HbA1c)

Secondary outcomes

  1. BMI (kg/cm2)

    Time frame: At baseline, 3 and 6 months

    BMI (kg/cm2)

  2. Satisfaction of patients

    Time frame: At 6 months

    Score in the satisfaction questionnaire

  3. Physical exercise index

    Time frame: At baseline, 3 and 6 months

    Physical exercise index (IPAQ)

  4. Compliance with the triple dietary intervention

    Time frame: At 3 and 6 months

    Compliance with the triple dietary intervention

  5. Percentage of patients who reach normoglycemia (HbA1c < 5.7)

    Time frame: At 3 and 6 months

    Prcentage of patients who reach normoglycemia (HbA1c < 5.7).

Study contacts

Contact information is provided by the study sponsor or research team.

ANTXON GENERAL PRACTITIONNER

CONTACT

[email protected]

945207935

Sponsors and collaborators

Lead sponsor

Bioaraba Health Research Institute

Network

Registry information

Official study title

EFFECTIVENESS OF A TRIPLE NUTRITIONAL INTERVENTION AND PHYSICAL ACTIVITY FOR GLYCOSYLATED HB CONTROL IN PREDIABETICS: CLINICAL TRIAL

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2025
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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