Diabetes Mellitus, Type 2NCT02456064
Impact of a Program of Non-pharmacological Intervention in Patients With Type 2 Diabetes Mellitus
A study testing Lifestyle counseling in people with Diabetes Mellitus, Type 2, run by Equipo Multidisciplinar Sanitario CS Foietes.
Trial summary
The purpose of this study is to determine whether a non-drug intensive program can help improve control of type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jan 2016
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes mellitus with poor control of their disease.
- No changes have been made in pharmacological previous 3 months.
Who cannot join
- Changes in their drug treatment in the past 3 months.
About this study
Official title: Impact of a Program of Non-pharmacological Intervention in Patients With Type 2 Diabetes Mellitus With Poor Control of Their Disease
The purpose of this study is to determine whether a non-drug intensive program can help improve control of type 2 diabetes mellitus.
Read the detailed description
This study is based on the creation of two groups of patients with type 2 diabetes mellitus over a period of six months .
In one of the groups an intensive program be developed through : group medical consultations , workshops , informative talks, " expert patient " telephone inquiries .. etc. Meanwhile , the control group that will be followed in the consultations as usual.
We will make a determination of HbA1c at 3 months and 6 months later to assess whether there are significant differences between the two groups .
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Lifestyle counseling
- 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.
Lifestyle counselingBehavioural
- Group medical visits
- Telephone medical consultations
- Expert patient
- Training workshops
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | In this group we will make an intensive program based on: workshops, educational talks, group medical practices and "expert patient" among others conduct auditions. Receives: Behavioral: Lifestyle counseling |
| Normal group | No intervention | In this group will be controlled as usual in the consultations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2015
- Study completionJan 2016
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Equipo Multidisciplinar Sanitario CS Foietes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivan S Silvera, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456064
- Sponsor's protocol ID
- Equipo Multidisciplinar
- Status last verified
- Mar 2017
- First submitted
- 24 May 2015
- Last updated
- 28 Mar 2017
- 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 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Program of Non-pharmacological Intervention in Patients With Type 2 Diabetes Mellitus With Poor Control of Their Disease
- ClinicalTrials.gov ID
- NCT02456064
- Acronym / sponsor ID
- Equipo Multidisciplinar
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Equipo Multidisciplinar Sanitario CS FoietesUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 28 May 2015 (estimated)
- 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.
The purpose of this study is to determine whether a non-drug intensive program can help improve control of type 2 diabetes mellitus.
Detailed description
This study is based on the creation of two groups of patients with type 2 diabetes mellitus over a period of six months .
In one of the groups an intensive program be developed through : group medical consultations , workshops , informative talks, " expert patient " telephone inquiries .. etc. Meanwhile , the control group that will be followed in the consultations as usual.
We will make a determination of HbA1c at 3 months and 6 months later to assess whether there are significant differences between the two groups .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Lifestyle counselingIn this group we will make an intensive program based on: workshops, educational talks, group medical practices and "expert patient" among others conduct auditions. |
| Normal group | No intervention | –In this group will be controlled as usual in the consultations. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with type 2 diabetes mellitus with poor control of their disease.
- No changes have been made in pharmacological previous 3 months.
Key exclusion criteria (1 listed)
- Changes in their drug treatment in the past 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 |
|---|---|---|
| Lifestyle counseling* Group medical visits * Telephone medical consultations * Expert patient * Training workshops | Behavioural | Lifestyle counseling |
Primary outcome
HbA1c
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- 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.
Ivan S Silvera principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle counseling in people with Diabetes Mellitus, Type 2, run by Equipo Multidisciplinar Sanitario CS Foietes.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 6 months). 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 28 Mar 2017.