An interventional study of Participants will receive the AMENUCED program including medical care, nutritional counseling, and structured sessions focused on behavioral change and diabetes education. in Diabete Type 2, sponsored by Universidad de Sonora. Completed at 1 site in Mexico. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-25.
Sponsored by Universidad de Sonora · Not applicable, Interventional, and Treatment
Among 451 studies in Diabetes Mellitus, Type 2 with a site in Mexico — 27 open to participants now, 43 under way, 18 of them phase 3. Diabetes Mellitus, Type 2 · Mexico.
Among the 451 studies in Diabetes Mellitus, Type 2 with a site in Mexico, this one is the 421st largest by enrollment of the 427 interventional ones that give a count, is one of 10 that started in 2025, is one of 43 with no phase, and was the 426th registered.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 5 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →27 of the 451 studies in Diabetes Mellitus, Type 2 with a site in Mexico are open now, in 12 countries. Each count lists the studies.
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →451 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 10 started in 2025.
Median enrollment 442 across the 427 interventional studies, 1,000 across the 23 observational. Of the 383 that completed or were terminated, 240 (63%) have results posted.
372 of 451 have an industry lead sponsor. The 10 most frequent:
Universidad de Sonora is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Universidad de Sonora has 2 studies filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
7 of the studies in Diabetes Mellitus, Type 2 with a site in Mexico that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07628985Phase 3Carnot LaboratoriesBALANCE-DM2 Study of Bofanglutide in Adults With Type 2 Diabetes | 2027-10 |
| NCT03811561Phase 3Novo Nordisk A/SA Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes | 2027-11-07 |
| NCT07401992Hospital Universitario Dr. Jose E. GonzalezEffects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis | 2027-02-28 |
| NCT06069518Coordinación de Investigación en Salud, MexicoContinuous Glucose Monitoring in Patients With Diabetes on Peritoneal Dialysis | 2027-03-31 |
| NCT06163248Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranChrono Nutrition and Insulin Resistance in Diabetes | 2027-04-01 |
Among the 451 studies in Diabetes Mellitus, Type 2 with a site in Mexico, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Diabetes-related complications, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: 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.
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.
Time frame: Baseline to 12 weeks post intervention
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 (%)
Time frame: Baseline to 12 weeks post intervention.
Change in Glycated Hemoglobin
Measured using standardized blood tests to assess glycemic control. Unit of Measure: %
Time frame: Baseline and 12 weeks post-intervention
Change in body fat
Measured in using medical body composition analyzer (Seca mBCA 514) under standardized conditions. Unit of measure (kg of body fat)
Time frame: Baseline and 12 weeks post-intervention
Change in Body Mass Index
Calculated as weight (kg) divided by height squared (m²), using standardized equipment and protocol. Unit of measure: kg/m²
Time frame: Baseline and 12 weeks post-intervention
Change in waist circumference
Measured with anthropometric tape (Lufkin Executive W606PMMX) at the umbilical level. Unit of measure: cm
Time frame: Baseline and 12 weeks post-intervention
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
Time frame: Baseline and 12 weeks post-intervention
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
Time frame: Baseline and 12 weeks post-intervention
Change in Fasting Glucose
Measured via standardized laboratory testing. Unit of Measure: mg/dL
Time frame: Baseline and 12 weeks post-intervention
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)
Time frame: Baseline and 12 weeks post-intervention.
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
Time frame: Baseline and 12 weeks post intervention.
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
Time frame: Baseline and 12 weeks post intervention.
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
Time frame: Baseline and 12 weeks post intervention.
Change in Total Cholesterol
Measured via standardized laboratory testing. Unit of Measure: mg/dL
Time frame: Baseline and 12 weeks post intervention
Change in HDL Cholesterol
Measured via standardized laboratory testing. Higher values indicated better cardiovascular profile. Unit of Measure: mg/dL
Time frame: Baseline and 12 weeks post intervention
Change in LDL Cholesterol
Measured via standardized laboratory testing. Unit of Measure: mg/dL
Time frame: Baseline and 12 weeks post intervention
Change in Triglycerides
Measured via standardized laboratory testing. Unit of Measure: mg/dL
Time frame: Baseline and 12 weeks post intervention
Plan to share: No — Individual participant data (IPD) will not be shared, as this study corresponds to a pilot phase with a small sample size.
No publications or documents are linked to this record.
Ran from Sep 2025 to primary completion in Dec 2025, 2 months.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 2 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Universidad de Sonora