Diabetes Mellitus, Type 2
Conditions
Keywords
Integrative Medicine, Diabetes Mellitus Type 2
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.
Interventions
OTHERIntegrative 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.
OTHERConventional treatment for T2DM
Conventional medical treatment for T2DM
Sponsors
TecSalud
Fundación Santos y de la Garza Evia I.B.P
TecSalud Investigación Clínica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c levels (%) | Baseline to 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting insulin (mU/mL) | 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 | — |
| 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 | — |
| 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 | — |
| Change in lifestyle instrument | Baseline to 12 weeks and 36 weeks | Instrument to measure diabetic lifestyles (IMEVID) total score |
Countries
Mexico
Contacts
Primary ContactRegina Moreno, MD
Outcome results
None listed