Diabetes MellitusNCT00935805
Glycemic And Blood Pressure Control In Type 2 Diabetes, In A Primary Care Unit: A Staged Management Strategy
An observational study of Diabetes Mellitus and Arterial Hypertension, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The aim of this study is to to analyze if it is possible to reach the goals of HbA1c <7.0% and blood pressure <= 130/80 mm Hg in a cohort of patients with type 2 diabetes attending a primary care unit, using ony those resources available at the unit, and provided by the Brazilian National Health System. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Diabetes Mellitus, Arterial Hypertension
- What is being tested?
- Metformin, Glybenclamide and NPH insulin
- Type of treatment
- Pill or oral medicine
- How many people
- 124 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2006to Jul 2012
- Phase
- Observational
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 diabetic patients attending a primary care outpatient facility
Who may be able to join
- Type 2 diabetes mellitus (WHO)
Who cannot join
- Terminal disease (renal, cancer, heart failure)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: ANALYSIS OF THE EFFECTIVENESS OF A STAGED MANAGEMENT PROGRAM AIMED AT CONTROLLING BLOOD PRESSURE AND BLOOD GLUCOSE OF TYPE 2 DIABETIC PATIENTS USING EXCLUSIVELY THE RESOURCES AVAILABLE IN A PRIMARY CARE SETTING IN BRAZIL
The aim of this study is to to analyze if it is possible to reach the goals of HbA1c <7.0% and blood pressure <= 130/80 mm Hg in a cohort of patients with type 2 diabetes attending a primary care unit, using ony those resources available at the unit, and provided by the Brazilian National Health System. It is an open label, observational study, with a duration of 4-6 years. Patients attending a primary care outpatient facility will be sequentially included in the study provided they give consent. They will be followed on a monthly basis by a team of physicians and nurses. Glucose, A1c, Blood PRessure will be the outcomes.
- Conditions
- Diabetes Mellitus, Arterial Hypertension
- Being tested
- Metformin, Glybenclamide, NPH insulin, Hydrochlorothiazide, Propranolol
- Keywords
- Diabetes Mellitus, Arterial Hypertension, Treatment, Primary Care
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Initial drug added to non-pharmacological measures
850 mg TID
GlybenclamideDrug
Also called Second oral agent to be added
10 mg BID
NPH insulinDrug
Also called Insulin added to or substituted for OA
Variable SC dose
HydrochlorothiazideDrug
Also called Inital RX for hypertension
25 mg QD introduced as initial therapy for hypertension
PropranololDrug
Also called Introduced if diuretic + captopril do not control BP
40 mg BID
CaptoprilDrug
Also called Added to hydrochlorothiazide if BP not attained
50 mg TID
AmlodipineDrug
Also called Added to previous if BP control BP not satisfactory
10 mg QD
| Study group | Role | What they receive |
|---|---|---|
| Treatment | 124 patients attending the primary care unit included after formal consent. Receives: Drug: Metformin; Drug: Glybenclamide; Drug: NPH insulin; Drug: Hydrochlorothiazide; Drug: Propranolol; Drug: Captopril; Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin A1c
Measured: 3 months
Blood pressure
Measured: 1 month
Secondary outcomes (2)
24 hr blood glucose profile
Measured: once
Fasting blood glucose
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startJul 2006
- Primary completionJan 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
- Responsible party
- Sponsor
- Investigators
- Rogerio Friedman, MD, PhD, Principal investigator, Hospital de Clinicas de Porto AlegreJorge L Gross, MD, PhD, Study chair, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935805
- Sponsor's protocol ID
- 06260
- Status last verified
- Jul 2011
- First submitted
- 8 Jul 2009
- Last updated
- 26 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANALYSIS OF THE EFFECTIVENESS OF A STAGED MANAGEMENT PROGRAM AIMED AT CONTROLLING BLOOD PRESSURE AND BLOOD GLUCOSE OF TYPE 2 DIABETIC PATIENTS USING EXCLUSIVELY THE RESOURCES AVAILABLE IN A PRIMARY CARE SETTING IN BRAZIL
- ClinicalTrials.gov ID
- NCT00935805
- Acronym / sponsor ID
- 06260
- Conditions
- Diabetes Mellitus, Arterial Hypertension
- Keywords
- Diabetes Mellitus, Arterial Hypertension, Treatment, Primary Care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
- Study start
- Jul 2006
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 9 Jul 2009 (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 aim of this study is to to analyze if it is possible to reach the goals of HbA1c <7.0% and blood pressure <= 130/80 mm Hg in a cohort of patients with type 2 diabetes attending a primary care unit, using ony those resources available at the unit, and provided by the Brazilian National Health System. It is an open label, observational study, with a duration of 4-6 years. Patients attending a primary care outpatient facility will be sequentially included in the study provided they give consent. They will be followed on a monthly basis by a team of physicians and nurses. Glucose, A1c, Blood PRessure will be the outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Drug: Metformin, Drug: Glybenclamide, Drug: NPH insulin, Drug: Hydrochlorothiazide, Drug: Propranolol, Drug: Captopril, Drug: Amlodipine124 patients attending the primary care unit included after formal consent. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetic patients attending a primary care outpatient facility
Key inclusion criteria (1 listed)
- Type 2 diabetes mellitus (WHO)
Key exclusion criteria (1 listed)
- Terminal disease (renal, cancer, heart failure)
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 |
|---|---|---|
| MetforminAlso: Initial drug added to non-pharmacological measures850 mg TID | Drug | Treatment |
| GlybenclamideAlso: Second oral agent to be added10 mg BID | Drug | Treatment |
| NPH insulinAlso: Insulin added to or substituted for OAVariable SC dose | Drug | Treatment |
| HydrochlorothiazideAlso: Inital RX for hypertension25 mg QD introduced as initial therapy for hypertension | Drug | Treatment |
| PropranololAlso: Introduced if diuretic + captopril do not control BP40 mg BID | Drug | Treatment |
| CaptoprilAlso: Added to hydrochlorothiazide if BP not attained50 mg TID | Drug | Treatment |
| AmlodipineAlso: Added to previous if BP control BP not satisfactory10 mg QD | Drug | Treatment |
Primary outcome
Glycated hemoglobin A1c
Time frame: 3 months
Blood pressure
Time frame: 1 month
2 secondary outcomes
24 hr blood glucose profile
Time frame: once
Fasting blood glucose
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2011.
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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.
Rogerio Friedman, MD, PhD principal investigator
Hospital de Clinicas de Porto Alegre
Jorge L Gross, MD, PhD study chair
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Arterial Hypertension, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 26 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
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?
Glycated hemoglobin A1c (time frame: 3 months). The study lists 2 primary outcomes in all. 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 26 Oct 2011; AzTrials last refreshed its copy on 7 Nov 2026.