EFFECTIVENESS OF A TRIPLE NUTRITIONAL INTERVENTION AND PHYSICAL IN PREDIABETIC PATIENRS

Bioaraba Health Research Institute

Status: Not yet enrolling

Conditions: Diabetes

Treatments: Combination Product: A TRIPLE INTERVENTION NUTRITION AND PHYSICAL ACTIVITY

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06820775

PREDIABET01

Details and patient eligibility

About

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).

Enrollment: 82 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

INTERVENTIONAL GROUP

Experimental group

Description:

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

Treatment:

Combination Product: A TRIPLE INTERVENTION NUTRITION AND PHYSICAL ACTIVITY

CONTROL GROUP

No Intervention group

Description:

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