Integrative Group Program for Type 2 Diabetes Mellitus (T2DM)

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT05888454
• Lead Sponsor: Hospital San Jose Tec de Monterrey

Brief Summary

This is an open, randomized, controlled trial to determine the impact of an integrative group program on metabolic control and wellbeing perception of patients with T2DM. The integrative group program consists of 6 in-person sessions directed by a health coach and occurring every other week, and 6 asynchronous educative sessions during a period of 12 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-15
• Study First Submitted QC: 2023-05-25
• Study First Posted: 2023-06-05
• Study Start: 2023-07-24
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-29
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• T2DM diagnosis of less than 5 years
• Age 18 to 80 years
• Current residence in Nuevo León, México
• Availability to attend in-person sessions
• Provides written informed consent
• Able to read and write

Exclusion Criteria

• Currently under insulin treatment
• T2DM diagnosis more than 5 years ago
• Comorbidities such as active cancer, acquired immunodeficiency (HIV+, AIDS), liver, cardiovascular, renal, pulmonary or thyroid disease.
• History of severe neurologic or psychiatric disease (current or past diagnosis)
• Currently pregnant or intention of pregnancy in the following 3 months
• Males that consume more than 4 alcoholic beverages daily or 14 weekly
• Females that consume more than 3 alcoholic beverages daily or 7 weekly
• Consumption of any illicit drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c levels (%)	Baseline to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Fasting insulin (mU/mL)	Baseline to 12 weeks and 36 weeks
High-sensitivity C-reactive protein (hs-CRP, mg/dL)	Baseline to 12 weeks and 36 weeks
Fasting glucose (mg/dL)	Baseline to 12 weeks and 36 weeks
Homeostatic Model Assessment (HOMA index)	Baseline to 12 weeks and 36 weeks
Change in lifestyle instrument	Baseline to 12 weeks and 36 weeks	Instrument to measure diabetic lifestyles (IMEVID) total score
Subjective sense of wellbeing instrument	Baseline to 12 weeks and 36 weeks	Positive emotion, Engagement, Relationships, Meaning, and Accomplishment (PERMA-profiler) score
Adherence to pharmacological interventions for T2DM	Baseline to 12 weeks and 36 weeks	Adherence to Refill and Medication Scale (ARMS) score
Change in dose of pharmacological interventions for T2DM	Baseline to 12 weeks and 36 weeks
HbA1c levels (%)	Baseline to 12 weeks and 36 weeks

Trial Locations

Locations (2)

Centro Médico Zambrano Hellion, Fundación Santos y de la Garza Evia I.B.P, TecSalud; 🇲🇽 San Pedro Garza Garcia, Nuevo León, Mexico

Centro de Salud Integral, Fundación Santos y de la Garza Evia I.B.P, TecSalud; 🇲🇽 Santa Catarina, Nuevo León, Mexico