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Diabete Type 2AMENUCEDNCT07186686

Feasibility Study of AMENUCED Program in Type 2 Diabetes

A study testing Participants will receive the AMENUCED program including medical care, nutritional counseling, and structured sessions focused on behavioral change and diabetes education. in people with Diabete Type 2, run by Universidad de Sonora at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Diabete Type 2
What is being tested?
Participants will receive the AMENUCED program including medical care, nutritional counseling, and structured sessions focused on behavioral change and diabetes education.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteMexico
Study dates
18 Sep 2025to 12 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Diabetes-related complications, including:
  • Advanced diabetic nephropathy
  • Neuropathy
  • Retinopathy
  • Cardiovascular or cerebrovascular diseases
  • History of severe hypoglycemia
Show all 17Show fewer
  • 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 locations and contacts

1 site in 1 country.

Mexico1 site

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

    Hermosillo, Sonora, 83000

Other trials in Mexico

About this study

Official title: Development of the AMENUCED Program and Evaluation of Its Feasibility in Adults With Type 2 Diabetes: A Pre-Post Study

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
Being tested
Participants will receive the AMENUCED program including medical care, nutritional counseling, and structured sessions focused on behavioral change and diabetes education.
Keywords
Type 2 Diabetes Mellitus, Pilot Study, Feasibility, Self management education, Lifestyle intervention
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT07186686
Study groupRoleWhat they receive
AMENUCED Intervention GroupExperimentalParticipants 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.
Receives: Other: Participants will receive the AMENUCED program including medical care, nutritional counseling, and structured sessions focused on behavioral change and diabetes education.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptance of the AMENUCED Program

    Acceptance will be assessed by participant ratings using a 1-10 scale (where 1= lowest acceptance and 10 = highest acceptance) for each component of the program, including educational content, delivery format, and perceived usefulness. Unit of measure: Score 1 - 10.

    Measured: Baseline to 12 weeks post intervention

  2. Retention in the AMENUCED Program

    Retention will be measured by the percentage of participants who remain in the program. Unit of Measure: Percentage of participants (%)

    Measured: Baseline to 12 weeks post intervention.

Secondary outcomes (15)

  1. Change in Glycated Hemoglobin

    Measured using standardized blood tests to assess glycemic control. Unit of Measure: %

    Measured: Baseline and 12 weeks post-intervention

  2. Change in body fat

    Measured in using medical body composition analyzer (Seca mBCA 514) under standardized conditions. Unit of measure (kg of body fat)

    Measured: Baseline and 12 weeks post-intervention

  3. Change in Body Mass Index

    Calculated as weight (kg) divided by height squared (m²), using standardized equipment and protocol. Unit of measure: kg/m²

    Measured: Baseline and 12 weeks post-intervention

  4. Change in waist circumference

    Measured with anthropometric tape (Lufkin Executive W606PMMX) at the umbilical level. Unit of measure: cm

    Measured: Baseline and 12 weeks post-intervention

  5. Change in Blood Pressure

    Systolic and diastolic blood pressure will be measured using an Omron digital sphygmomanometer (HEM-907XL) on the upper arm, following American Heart Association guidelines. Unit of Measure: mmHg

    Measured: Baseline and 12 weeks post-intervention

  6. Change in Health-Related Quality of Life

    Assessed using the "SF-36 Health Survey", with scores ranging from 0 = worst possible health status, to 100 = best possible health status. Unit of measure: 0 - 100

    Measured: Baseline and 12 weeks post-intervention

  7. Change in Fasting Glucose

    Measured via standardized laboratory testing. Unit of Measure: mg/dL

    Measured: Baseline and 12 weeks post-intervention

  8. Change in Perceived Stress

    Assessed using "The Coping Stress Questionnaire (CAE): Validation in a Mexican Sample". The CAE includes seven subscales: problem-solving focus, negative self-focus, positive reappraisal, open emotional expression, avoidance, social support seeking and religious coping. Participants rate each item on a 6-point Likert scale (0 = never, 5 = always). Higher scores indicate more frequent use of the corresponding coping strategy. Use of Measure: Subscale scores (range: 0-5 per item; total score varies by subscale)

    Measured: Baseline and 12 weeks post-intervention.

  9. Change in Depression Symptoms

    Assessed using the Beck Depression Inventory-II, a 21 item self-report questionnaire designed to measure the severity of depression. Each item is rated on a 4 point Likert scale (0 = not al all, 3 = severe), with total scores ranging from 0 to 63. Higher scores indicate greater severity of depressive symptoms. Unit of Measure: Total score range 0 - 63

    Measured: Baseline and 12 weeks post intervention.

  10. Change in Anxiety Symptoms

    Assessed using the "Beck Anxiety Inventory (BIA), a 21 item self report questionnaire designed to measure the severity of anxiety in adults. Each item is rated on a 4 point likert scale (0 = not al all, 3 = severely), with total scores ranging from 0 to 63. Higher scores indicate greater severity of anxiety symptoms. The BAI has demonstrated strong psychometric properties in general Mexican populations. Unit of Measure: Total score range 0 - 63

    Measured: Baseline and 12 weeks post intervention.

  11. Change in Diabetes Knowledge

    Assessed using the "24 - item version of the Diabetes Knowledge Questionnaire (DKQ-24), developed and validated in Spanish for Mexican-American populations. Each item is scored as correct or incorrect, with total scores ranging from 0 to 24. Higher scores indicate greater diabetes-related knowledge. Unit of Measure: Total score, range 0 - 24

    Measured: Baseline and 12 weeks post intervention.

  12. Change in Total Cholesterol

    Measured via standardized laboratory testing. Unit of Measure: mg/dL

    Measured: Baseline and 12 weeks post intervention

  13. Change in HDL Cholesterol

    Measured via standardized laboratory testing. Higher values indicated better cardiovascular profile. Unit of Measure: mg/dL

    Measured: Baseline and 12 weeks post intervention

  14. Change in LDL Cholesterol

    Measured via standardized laboratory testing. Unit of Measure: mg/dL

    Measured: Baseline and 12 weeks post intervention

  15. Change in Triglycerides

    Measured via standardized laboratory testing. Unit of Measure: mg/dL

    Measured: Baseline and 12 weeks post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2025
  2. Study start18 Sep 2025
  3. Primary completion3 Dec 2025
  4. Study completion12 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single-arm interventional study where all participants received the AMENUCED program.
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07186686
Sponsor's protocol ID
AMENUCED-DT2-01
Acronym
AMENUCED
Status last verified
Mar 2026
First submitted
2 Sep 2025
Last updated
25 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared, as this study corresponds to a pilot phase with a small sample size.

Questions about this trial

What is this clinical trial studying?

A study testing Participants will receive the AMENUCED program including medical care, nutritional counseling, and structured sessions focused on behavioral change and diabetes education. in people with Diabete Type 2, run by Universidad de Sonora at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptance of the AMENUCED Program (time frame: Baseline to 12 weeks post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07186686.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.

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