Feasibility Study of AMENUCED Program in Type 2 Diabetes

Universidad de Sonora

Status: Not yet enrolling

Conditions: Diabete Type 2

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07186686

AMENUCED-DT2-01

Details and patient eligibility

About

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.

Enrollment: 5 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

AMENUCED Intervention Group

Experimental group

Description:

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.

Treatment:

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