Integrative Group Program for Type 2 Diabetes Mellitus (T2DM)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Dando Pasos Juntos: An Integrative Group Program for Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05888454
• Other study ID #: Dando pasos juntos
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2023
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: Hospital San Jose Tec de Monterrey
• Contact: Regina Moreno, MD
• Phone: +52 33 367 668 77
• Email: regina.moreno[@]tecsalud.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Integrative Group Program
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.
• Conventional treatment for T2DM
Conventional medical treatment for T2DM

Locations

Country	Name	City	State
Mexico	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

Sponsors (3)

Lead Sponsor	Collaborator
Hospital San Jose Tec de Monterrey	Fundación Santos y de la Garza Evia I.B.P, TecSalud

Country where clinical trial is conducted

Mexico, 

Outcome

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