EFFECTIVENESS OF A TRIPLE NUTRITIONAL INTERVENTION AND PHYSICAL IN PREDIABETIC PATIENRS

February 10, 2025 updated by: ANTXON APIÑANIZ, Bioaraba Health Research Institute

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Alava
      • Vitoria-gasteiz, Alava, Spain
        • Antxon Apiñaniz
        • Contact:
          • ANTXON APIÑANIZ
          • Phone Number: 945207935

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: INTERVENTIONAL 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 (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

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.
No Intervention: CONTROL GROUP
Patients will receive the same attention as provided in routine clinical practice,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycated hemoglobin (HbA1c)
Time Frame: At baseline, 3 and 6 months
Glycated hemoglobin (HbA1c)
At baseline, 3 and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI (kg/cm2)
Time Frame: At baseline, 3 and 6 months
BMI (kg/cm2)
At baseline, 3 and 6 months
Satisfaction of patients
Time Frame: At 6 months
Score in the satisfaction questionnaire
At 6 months
Physical exercise index
Time Frame: At baseline, 3 and 6 months
Physical exercise index (IPAQ)
At baseline, 3 and 6 months
Compliance with the triple dietary intervention
Time Frame: At 3 and 6 months
Compliance with the triple dietary intervention
At 3 and 6 months
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).
At 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bioaraba Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 2, 2025

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

February 6, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREDIABET01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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