Diabetes Mellitus, Type 2NCT05888454
Integrative Group Program for Type 2 Diabetes Mellitus (T2DM)
A study testing Integrative Group Program and Conventional treatment for T2DM in people with Diabetes Mellitus, Type 2, run by TecSalud Investigación Clínica at 2 sites in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Integrative Group Program and Conventional treatment for T2DM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesMexico
- Study dates
- 24 Jul 2023to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites, 2 recruiting
- Recruiting
Centro Médico Zambrano Hellion, Fundación Santos y de la Garza Evia I.B.P, TecSalud
San Pedro Garza García, Nuevo León, 66278
Regina Moreno, MD, +52 33 367 668 77, regina.moreno@tecsalud.mx
Tania Zertuche, MD
- Recruiting
Centro de Salud Integral, Fundación Santos y de la Garza Evia I.B.P, TecSalud
Santa Catarina, Nuevo León, 66369
Regina Moreno, MD, +52 33 367 668 77, regina.moreno@tecsalud.mx
Tania Zertuche, MD
About this study
Official title: Dando Pasos Juntos: An Integrative Group Program for Type 2 Diabetes Mellitus
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Integrative Group Program, Conventional treatment for T2DM
- Keywords
- Integrative Medicine, Diabetes Mellitus Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Conventional treatment for T2DMOther
Conventional medical treatment for T2DM
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Conventional treatment for T2DM + Integrative Group Program Receives: Other: Integrative Group Program; Other: Conventional treatment for T2DM |
| Control Group | Active comparator | Conventional treatment for T2DM Receives: Other: Conventional treatment for T2DM |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c levels (%)
Measured: Baseline to 12 weeks
Secondary outcomes (9)
HbA1c levels (%)
Measured: Baseline to 12 weeks and 36 weeks
Fasting insulin (mU/mL)
Measured: Baseline to 12 weeks and 36 weeks
Fasting glucose (mg/dL)
Measured: Baseline to 12 weeks and 36 weeks
Homeostatic Model Assessment (HOMA index)
Measured: Baseline to 12 weeks and 36 weeks
High-sensitivity C-reactive protein (hs-CRP, mg/dL)
Measured: Baseline to 12 weeks and 36 weeks
Change in lifestyle instrument
Instrument to measure diabetic lifestyles (IMEVID) total score
Measured: Baseline to 12 weeks and 36 weeks
Subjective sense of wellbeing instrument
Positive emotion, Engagement, Relationships, Meaning, and Accomplishment (PERMA-profiler) score
Measured: Baseline to 12 weeks and 36 weeks
Adherence to pharmacological interventions for T2DM
Adherence to Refill and Medication Scale (ARMS) score
Measured: Baseline to 12 weeks and 36 weeks
Change in dose of pharmacological interventions for T2DM
Measured: Baseline to 12 weeks and 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start24 Jul 2023
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TecSalud Investigación Clínica
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Santos y de la Garza Evia I.B.P
- Responsible party
- Sponsor
- Investigators
- Tania Zertuche, MD, Principal investigator, Director de Instituto de Bienestar y Prevención
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888454
- Sponsor's protocol ID
- Dando pasos juntos
- Status last verified
- Feb 2024
- First submitted
- 15 May 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dando Pasos Juntos: An Integrative Group Program for Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05888454
- Acronym / sponsor ID
- Dando pasos juntos
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Integrative Medicine, Diabetes Mellitus Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- TecSalud Investigación ClínicaUniversity, hospital or other
- Collaborators
- Fundación Santos y de la Garza Evia I.B.P
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Integrative Group Program, Other: Conventional treatment for T2DMConventional treatment for T2DM + Integrative Group Program |
| Control Group | Active comparator | Other: Conventional treatment for T2DMConventional treatment for T2DM |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative Group ProgramThe 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. | Other | Experimental Group |
| Conventional treatment for T2DMConventional medical treatment for T2DM | Other | Control Group, Experimental Group |
Primary outcome
HbA1c levels (%)
Time frame: Baseline to 12 weeks
9 secondary outcomes
HbA1c levels (%)
Time frame: Baseline to 12 weeks and 36 weeks
Fasting insulin (mU/mL)
Time frame: Baseline to 12 weeks and 36 weeks
Fasting glucose (mg/dL)
Time frame: Baseline to 12 weeks and 36 weeks
Homeostatic Model Assessment (HOMA index)
Time frame: Baseline to 12 weeks and 36 weeks
High-sensitivity C-reactive protein (hs-CRP, mg/dL)
Time frame: Baseline to 12 weeks and 36 weeks
Change in lifestyle instrument
Time frame: Baseline to 12 weeks and 36 weeks
Subjective sense of wellbeing instrument
Time frame: Baseline to 12 weeks and 36 weeks
Adherence to pharmacological interventions for T2DM
Time frame: Baseline to 12 weeks and 36 weeks
Change in dose of pharmacological interventions for T2DM
Time frame: Baseline to 12 weeks and 36 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tania Zertuche, MD principal investigator
Director de Instituto de Bienestar y Prevención
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative Group Program and Conventional treatment for T2DM in people with Diabetes Mellitus, Type 2, run by TecSalud Investigación Clínica at 2 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Regina Moreno, MD (+52 33 367 668 77, regina.moreno@tecsalud.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c levels (%) (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.