EFFECTIVENESS OF A TRIPLE NUTRITIONAL INTERVENTION AND PHYSICAL IN PREDIABETIC PATIENRS

NCT06820775 | Not Yet Recruiting

• 1 other identifier: PREDIABET01
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes

Keywords

DIABETES MELLITUS

Outcome Measures

Primary Outcomes (1)

• Glycated hemoglobin (HbA1c)

  Glycated hemoglobin (HbA1c)

  At baseline, 3 and 6 months

Secondary Outcomes (5)

• BMI (kg/cm2)

  At baseline, 3 and 6 months

• Satisfaction of patients

  At 6 months

• Physical exercise index

  At baseline, 3 and 6 months

• Compliance with the triple dietary intervention

  At 3 and 6 months

• Percentage of patients who reach normoglycemia (HbA1c < 5.7)

  At 3 and 6 months

Study Arms (2)

INTERVENTIONAL GROUP

EXPERIMENTAL

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 (42-44). Likewise, the nurse will give healthy eating recommendations according to the Osakidetza guide (41): 1.1 Recommendation sports practice: ecommendation 1: \>\>All persons aged 18 years and older should accumulate a minimum of 150 minutes per week of moderate aerobic physical activity, or 75 minutes of vigorous aerobic physical activity each week, or an equivalent combination of moderate and vigorous activities. Exercise should be in sessions of at least 10 minutes. Recommendation 2: Twice or more times per week, it is advisable to

Combination Product: A TRIPLE INTERVENTION NUTRITION AND PHYSICAL ACTIVITY

CONTROL GROUP

NO INTERVENTION

Patients will receive the same attention as provided in routine clinical practice,

Interventions

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.

INTERVENTIONAL GROUP

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioaraba Health Research Institute: lead

Study Sites (1)

Antxon Apiñaniz

Vitoria-Gasteiz, Alava, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

ANTXON GENERAL PRACTITIONNER

CONTACT

945207935; ANTXON.APINANIZFERNANDEZ@OSAKIDETZA.EUS

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: GENERAL PRACTITIONNER

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: February 2, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

ES (1)