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Integrative Group Program for Type 2 Diabetes Mellitus (T2DM)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Not yet recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Integrative Group Program
Conventional treatment for T2DM
Sponsored by
Hospital San Jose Tec de Monterrey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Integrative Medicine, Diabetes Mellitus Type 2

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro Médico Zambrano Hellion, Fundación Santos y de la Garza Evia I.B.P, TecSalud
  • Centro de Salud Integral, Fundación Santos y de la Garza Evia I.B.P, TecSalud

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

Conventional treatment for T2DM + Integrative Group Program

Conventional treatment for T2DM

Outcomes

Primary Outcome Measures

HbA1c levels (%)

Secondary Outcome Measures

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

Full Information

First Posted
May 15, 2023
Last Updated
September 21, 2023
Sponsor
Hospital San Jose Tec de Monterrey
Collaborators
TecSalud, Fundación Santos y de la Garza Evia I.B.P
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1. Study Identification

Unique Protocol Identification Number
NCT05888454
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital San Jose Tec de Monterrey
Collaborators
TecSalud, Fundación Santos y de la Garza Evia I.B.P

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Integrative Medicine, Diabetes Mellitus Type 2

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Conventional treatment for T2DM + Integrative Group Program
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Conventional treatment for T2DM
Intervention Type
Other
Intervention Name(s)
Integrative Group Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional treatment for T2DM
Intervention Description
Conventional medical treatment for T2DM
Primary Outcome Measure Information:
Title
HbA1c levels (%)
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
HbA1c levels (%)
Time Frame
Baseline to 12 weeks and 36 weeks
Title
Fasting insulin (mU/mL)
Time Frame
Baseline to 12 weeks and 36 weeks
Title
Fasting glucose (mg/dL)
Time Frame
Baseline to 12 weeks and 36 weeks
Title
Homeostatic Model Assessment (HOMA index)
Time Frame
Baseline to 12 weeks and 36 weeks
Title
High-sensitivity C-reactive protein (hs-CRP, mg/dL)
Time Frame
Baseline to 12 weeks and 36 weeks
Title
Change in lifestyle instrument
Description
Instrument to measure diabetic lifestyles (IMEVID) total score
Time Frame
Baseline to 12 weeks and 36 weeks
Title
Subjective sense of wellbeing instrument
Description
Positive emotion, Engagement, Relationships, Meaning, and Accomplishment (PERMA-profiler) score
Time Frame
Baseline to 12 weeks and 36 weeks
Title
Adherence to pharmacological interventions for T2DM
Description
Adherence to Refill and Medication Scale (ARMS) score
Time Frame
Baseline to 12 weeks and 36 weeks
Title
Change in dose of pharmacological interventions for T2DM
Time Frame
Baseline to 12 weeks and 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Regina Moreno, MD
Phone
+52 33 367 668 77
Email
regina.moreno@tecsalud.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tania Zertuche, MD
Organizational Affiliation
Director de Instituto de Bienestar y Prevención
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Médico Zambrano Hellion, Fundación Santos y de la Garza Evia I.B.P, TecSalud
City
San Pedro Garza Garcia
State/Province
Nuevo León
ZIP/Postal Code
66278
Country
Mexico
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regina Moreno, MD
Phone
+52 33 367 668 77
Email
regina.moreno@tecsalud.mx
First Name & Middle Initial & Last Name & Degree
Tania Zertuche, MD
Facility Name
Centro de Salud Integral, Fundación Santos y de la Garza Evia I.B.P, TecSalud
City
Santa Catarina
State/Province
Nuevo León
ZIP/Postal Code
66369
Country
Mexico
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regina Moreno, MD
Phone
+52 33 367 668 77
Email
regina.moreno@tecsalud.mx
First Name & Middle Initial & Last Name & Degree
Tania Zertuche, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Integrative Group Program for Type 2 Diabetes Mellitus (T2DM)

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