CompletedNot Applicable

Feasibility Study of AMENUCED Program in Type 2 Diabetes

Mexico5 participantsStarted 2025-09-18

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acceptance of the AMENUCED Program

Timeframe: Baseline to 12 weeks post intervention

Retention in the AMENUCED Program

Timeframe: Baseline to 12 weeks post intervention.

Trial details

NCT IDNCT07186686

SponsorUniversidad de Sonora

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-03

View on ClinicalTrials.gov More Diabete Type 2 trials