Feasibility Study of AMENUCED Program in Type 2 Diabetes

NCT ID: NCT07186686

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2025-12-31

Brief Summary

Type 2 diabetes is characterized by progressive resistance to the effects of insulin, along with deficient insulin production. In Mexico, it affects 18.4% of adults and is the second leading cause of death. According to ENSANUT 2023, 74.2% of adults with diabetes have poor glycemic control. Achieving adequate glycemic control requires multiple interventions. The AMENUCED program is multicomponent and includes medical care, nutritional guidance, lifestyle support, and diabetes education. Each component has independently shown positive outcomes in diabetes management, yet few Mexicans receive this comprehensive care.

This study aims to develop the AMENUCED program and evaluate its feasibility (acceptance and retention) after a 3-month intervention in adults with type 2 diabetes.

A pre-post pilot study will be conducted. The primary outcome is program feasibility, while secondary outcomes include HbA1c, body weight, BMI, waist circumference, body fat, fasting glucose, plasma lipids, blood pressure, mental health aspects, and diabetes knowledge. Statistical analysis will be exploratory, using paired t-tests or Wilcoxon tests to compare pre- and post-intervention data, and McNemar's test to compare proportions.

Conditions

Diabete Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AMENUCED Intervention Group

Participants will receive the AMENUCED program including medical care, nutritional counseling, and structured sessions focused on behavioral change and diabetes education. The study is designed to assess the feasibility and acceptability of the AMANUCED program in adults with Type 2 Diabetes. This intervention does not involve any pharmacological or device-based components.

Group Type: EXPERIMENTAL

Participants will receive the AMENUCED program including medical care, nutritional counseling, and structured sessions focused on behavioral change and diabetes education.

Intervention Type: OTHER

Medical Attention: Medical management will be provided by a physician who will assess the participant at the beginning and end of the intervention. The physician will be responsible for pharmacological treatment and follow-up throughout the process.

Nutritional Attention: Nutritional consultations will be provided by a registered nutritionist over a three-month period, with sessions held weekly. During each consultation, the participant will receive an individualized nutrition plan based on scientific evidence and dietary recommendations. The plan will be tailored to the participant's specific needs, including metabolic control and a hypocaloric intake (ranging from 1200 to 1800 kcal), with the goal of achieving a 5-10% reduction in body weight.

Behavioral Lifestyle Change Program: The behavior modification program used in the Action for Health in Diabetes Program (Look AHEAD) study will be adapted to include diabetes self-management activities through a structured manual.

Interventions

Participants will receive the AMENUCED program including medical care, nutritional counseling, and structured sessions focused on behavioral change and diabetes education.

Medical Attention: Medical management will be provided by a physician who will assess the participant at the beginning and end of the intervention. The physician will be responsible for pharmacological treatment and follow-up throughout the process.

Nutritional Attention: Nutritional consultations will be provided by a registered nutritionist over a three-month period, with sessions held weekly. During each consultation, the participant will receive an individualized nutrition plan based on scientific evidence and dietary recommendations. The plan will be tailored to the participant's specific needs, including metabolic control and a hypocaloric intake (ranging from 1200 to 1800 kcal), with the goal of achieving a 5-10% reduction in body weight.

Behavioral Lifestyle Change Program: The behavior modification program used in the Action for Health in Diabetes Program (Look AHEAD) study will be adapted to include diabetes self-management activities through a structured manual.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults aged ≥18 and ≤65 years
• Residing in Hermosillo, Sonora
• Body Mass Index (BMI) ≥25
• Prior diagnosis of Type 2 Diabetes
• Individuals who cannot read or write may be included if accompanied by someone willing to attend sessions and assist with comprehension
• Must have active medical insurance

Exclusion Criteria

• Diabetes-related complications, including:

• Advanced diabetic nephropathy
• Neuropathy
• Retinopathy
• Cardiovascular or cerebrovascular diseases
• History of severe hypoglycemia
• Significant metabolic dysregulation (HbA1c ≥10%)
• Use of insulin, sulfonylureas, or meglitinides
• Pregnancy or breastfeeding within the past 6 months
• Diagnosed psychiatric disorders
• Consumption of ≥14 alcoholic beverages per week
• Serious illnesses (e.g., cancer, liver failure, kidney disease)
• Chronic use of corticosteroids
• Plans to relocate during the study period
• Weight loss greater than 5% in the past three months
• History of bariatric surgery
• Any other medical, psychiatric, or behavioral condition that, in the investigator's judgment, may interfere with participation in the intervention

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Sonora

OTHER

Sponsor Role: lead

Responsible Party

Rolando Giovanni Díaz Zavala

Full-time professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro de Promoción de Salud Nutricional (CPSN), Hermosillo, Sonora 83000

Hermosillo, Sonora, Mexico

Countries

Mexico

Central Contacts

Rolando G Diaz Zavala, Doctor

Role: CONTACT

giovanni.diaz@unison.mx

+52 662 2893793 ext. 4630

Facility Contacts

Rolando G Díaz Zavala, Doctor

Role: primary

giovanni.diaz@unison.mx

6622893793 ext. 4632

Other Identifiers

AMENUCED-DT2-01

Identifier Type: -

Identifier Source: org_study_id