NCT05888454

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 24, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

11 months

First QC Date

May 15, 2023

Last Update Submit

February 27, 2024

Conditions

Diabetes Mellitus, Type 2

Keywords

Integrative MedicineDiabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

  • HbA1c levels (%)

    Baseline to 12 weeks

Secondary Outcomes (9)

  • HbA1c levels (%)

    Baseline to 12 weeks and 36 weeks

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Experimental Group

EXPERIMENTAL

Conventional treatment for T2DM + Integrative Group Program

Other: Integrative Group ProgramOther: Conventional treatment for T2DM

Control Group

ACTIVE COMPARATOR

Conventional treatment for T2DM

Other: Conventional treatment for T2DM

Interventions

Integrative Group ProgramOTHER

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.

Experimental Group
Conventional treatment for T2DMOTHER

Conventional medical treatment for T2DM

Control GroupExperimental Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

San Pedro Garza García, Nuevo León, 66278, Mexico

RECRUITING

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

Santa Catarina, Nuevo León, 66369, Mexico

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Tania Zertuche, MD

    Director de Instituto de Bienestar y Prevención

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Regina Moreno, MD

CONTACT

+52 33 367 668 77regina.moreno@tecsalud.mx

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2023

First Posted

June 5, 2023

Study Start

July 24, 2023

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

February 29, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

ME(2)