MedDataX Logo

Glycemic And Blood Pressure Control In Type 2 Diabetes, In A Primary Care Unit: A Staged Management Strategy

NCT ID: NCT00935805

Last Updated: 2011-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus Arterial Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment

124 patients attending the primary care unit included after formal consent.

Metformin

Intervention Type DRUG

850 mg TID

Glybenclamide

Intervention Type DRUG

10 mg BID

NPH insulin

Intervention Type DRUG

Variable SC dose

Hydrochlorothiazide

Intervention Type DRUG

25 mg QD introduced as initial therapy for hypertension

Propranolol

Intervention Type DRUG

40 mg BID

Captopril

Intervention Type DRUG

50 mg TID

Amlodipine

Intervention Type DRUG

10 mg QD

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Metformin

850 mg TID

Intervention Type DRUG

Glybenclamide

10 mg BID

Intervention Type DRUG

NPH insulin

Variable SC dose

Intervention Type DRUG

Hydrochlorothiazide

25 mg QD introduced as initial therapy for hypertension

Intervention Type DRUG

Propranolol

40 mg BID

Intervention Type DRUG

Captopril

50 mg TID

Intervention Type DRUG

Amlodipine

10 mg QD

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Initial drug added to non-pharmacological measures Second oral agent to be added Insulin added to or substituted for OA Inital RX for hypertension Introduced if diuretic + captopril do not control BP Added to hydrochlorothiazide if BP not attained Added to previous if BP control BP not satisfactory

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Type 2 diabetes mellitus (WHO)

Exclusion Criteria

* Terminal disease (renal, cancer, heart failure)
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

OTHER

Sponsor Role collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rogerio Friedman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre

Jorge L Gross, MD, PhD

Role: STUDY_CHAIR

Hospital de Clinicas de Porto Alegre

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

06260

Identifier Type: -

Identifier Source: org_study_id