NCT07186686Completed
Feasibility Study of AMENUCED Program in Type 2 Diabetes
Development of the AMENUCED Program and Evaluation of Its Feasibility in Adults With Type 2 Diabetes: A Pre-Post Study
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 5 (actual)
- First submitted
- 2 Sept 2025
- Start date
- 18 Sept 2025
- Primary completion date
- 3 Dec 2025
- Lead sponsor
- Universidad de Sonora
- Diseases
- Type 2 diabetes
- NCT number
- NCT07186686
What you commit to
- Study type: Interventional
- Participants enrolled: 5
- From 18 Sept 2025 to the primary completion date, 3 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chronic use of corticosteroids
Other illness
- Diabetes-related complications, including:
- Advanced diabetic nephropathy
- Neuropathy
- Retinopathy
- Cardiovascular or cerebrovascular diseases
- History of severe hypoglycemia
- Diagnosed psychiatric disorders
- Serious illnesses (e.g., cancer, liver failure, kidney disease)
- History of bariatric surgery
- Any other medical, psychiatric, or behavioral condition that, in the investigator's judgment, may interfere with participation in the intervention
Lab values
- Significant metabolic dysregulation (HbA1c ≥10%)
Other
- Use of insulin, sulfonylureas, or meglitinides
- Pregnancy or breastfeeding within the past 6 months
- Consumption of ≥14 alcoholic beverages per week
- Plans to relocate during the study period
- Weight loss greater than 5% in the past three months
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Promoción de Salud Nutricional (CPSN), Hermosillo, Sonora 83000 Coordinator of this site? Confirm its status | Hermosillo | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.