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

Hospital San Jose Tec de Monterrey2 sites in 1 country120 target enrollmentJuly 24, 2023

ConditionsDiabetes Mellitus, Type 2

Overview

Phase: N/A
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 2
Sponsor: Hospital San Jose Tec de Monterrey
Enrollment: 120
Locations: 2
Primary Endpoint: HbA1c levels (%)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 24, 2023

End Date

July 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hospital San Jose Tec de Monterrey

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

HbA1c levels (%)

Time Frame: Baseline to 12 weeks

Secondary Outcomes

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)
HbA1c levels (%)(Baseline to 12 weeks and 36 weeks)
Fasting glucose (mg/dL)(Baseline to 12 weeks and 36 weeks)
Change in lifestyle instrument(Baseline to 12 weeks and 36 weeks)
Homeostatic Model Assessment (HOMA index)(Baseline to 12 weeks and 36 weeks)
Subjective sense of wellbeing instrument(Baseline to 12 weeks and 36 weeks)
Adherence to pharmacological interventions for T2DM(Baseline to 12 weeks and 36 weeks)
Change in dose of pharmacological interventions for T2DM(Baseline to 12 weeks and 36 weeks)