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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Conselho Nacional de Desenvolvimento Científico e Tecnológico

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

Information provided by (Responsible Party):

Hospital de Clinicas de Porto Alegre

ClinicalTrials.gov Identifier:

NCT00935805

First received: July 8, 2009

Last updated: October 25, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 8, 2009

Last Updated Date

October 25, 2011

Start Date ^ICMJE

July 2006

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Glycated hemoglobin A1c [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Blood pressure [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00935805 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

24 hr blood glucose profile [ Time Frame: once ] [ Designated as safety issue: No ]
Fasting blood glucose [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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. 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

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Type 2 diabetic patients attending a primary care outpatient facility

Condition ^ICMJE

Diabetes Mellitus
Arterial Hypertension

Intervention ^ICMJE

Drug: Metformin
850 mg TID

Other Name: Initial drug added to non-pharmacological measures
Drug: Glybenclamide
10 mg BID

Other Name: Second oral agent to be added
Drug: NPH insulin
Variable SC dose

Other Name: Insulin added to or substituted for OA
Drug: Hydrochlorothiazide
25 mg QD introduced as initial therapy for hypertension

Other Name: Inital RX for hypertension
Drug: Propranolol
40 mg BID

Other Name: Introduced if diuretic + captopril do not control BP
Drug: Captopril
50 mg TID

Other Name: Added to hydrochlorothiazide if BP not attained
Drug: Amlodipine
10 mg QD

Other Name: Added to previous if BP control BP not satisfactory

Study Group/Cohort (s)

Treatment

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

Interventions:

Drug: Metformin
Drug: Glybenclamide
Drug: NPH insulin
Drug: Hydrochlorothiazide
Drug: Propranolol
Drug: Captopril
Drug: Amlodipine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

124

Estimated Completion Date

July 2012

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Type 2 diabetes mellitus (WHO)

Exclusion Criteria:

Terminal disease (renal, cancer, heart failure)

Gender

Both

Ages

30 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT00935805

Other Study ID Numbers ^ICMJE

06260

Has Data Monitoring Committee

Responsible Party

Hospital de Clinicas de Porto Alegre

Study Sponsor ^ICMJE

Hospital de Clinicas de Porto Alegre

Collaborators ^ICMJE

Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Investigators ^ICMJE

Principal Investigator:	Rogerio Friedman, MD, PhD	Hospital de Clinicas de Porto Alegre
Study Chair:	Jorge L Gross, MD, PhD	Hospital de Clinicas de Porto Alegre

Information Provided By

Hospital de Clinicas de Porto Alegre

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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