Clinical trial NCT05888454: Integrative Group Program for Type 2 Diabetes Mellitus (T2DM)
Official title: Dando Pasos Juntos: An Integrative Group Program for Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Integrative Medicine
Diabetes Mellitus Type 2
Lead sponsor: TecSalud Investigación Clínica
Sponsor class: OTHER
Collaborators: name: TecSalud
name: Fundación Santos y de la Garza Evia I.B.P
First posted: 2023-06-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: HbA1c levels (%)
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: HbA1c levels (%)
timeFrame: Baseline to 12 weeks and 36 weeks
measure: Fasting insulin (mU/mL)
timeFrame: Baseline to 12 weeks and 36 weeks
measure: Fasting glucose (mg/dL)
timeFrame: Baseline to 12 weeks and 36 weeks
measure: Homeostatic Model Assessment (HOMA index)
timeFrame: Baseline to 12 weeks and 36 weeks
measure: High-sensitivity C-reactive protein (hs-CRP, mg/dL)
timeFrame: Baseline to 12 weeks and 36 weeks
measure: Change in lifestyle instrument
timeFrame: Baseline to 12 weeks and 36 weeks
measure: Subjective sense of wellbeing instrument
timeFrame: Baseline to 12 weeks and 36 weeks
measure: Adherence to pharmacological interventions for T2DM
timeFrame: Baseline to 12 weeks and 36 weeks
measure: Change in dose of pharmacological interventions for T2DM
timeFrame: Baseline to 12 weeks and 36 weeks
Other outcomes:
Locations:
city: San Pedro Garza Garcia
country: Mexico
facility: Centro Médico Zambrano Hellion, Fundación Santos y de la Garza Evia I.B.P, TecSalud
state: Nuevo León
city: Santa Catarina
country: Mexico
facility: Centro de Salud Integral, Fundación Santos y de la Garza Evia I.B.P, TecSalud
state: Nuevo León
Study officials:
affiliation: Director de Instituto de Bienestar y Prevención
name: Tania Zertuche, MD
role: PRINCIPAL_INVESTIGATOR
References: