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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Diabetes Mellitus Arterial Hypertension
Intervention	Drug: Metformin Drug: Glybenclamide Drug: NPH insulin Drug: Hydrochlorothiazide Drug: Propranolol Drug: Captopril Drug: Amlodipine
Phase	N/A
Sponsor	Hospital de Clinicas de Porto Alegre
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

Tracking Information[ + expand ][ + ]

First Received Date	July 8, 2009
Last Updated Date	October 25, 2011
Start Date	July 2006
Estimated Primary Completion Date	July 2012
Current Primary Outcome Measures	Glycated hemoglobin A1c [Time Frame: 3 months] [Designated as safety issue: No] Blood pressure [Time Frame: 1 month] [Designated as safety issue: No]
Current Secondary Outcome Measures	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]

Descriptive Information[ + expand ][ + ]

Brief Title	Glycemic And Blood Pressure Control In Type 2 Diabetes, In A Primary Care Unit: A Staged Management Strategy
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
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	Observational
Study Phase	N/A
Study Design	Observational Model: Cohort, Time Perspective: Prospective
Condition	Diabetes Mellitus Arterial Hypertension
Intervention	Drug: Metformin 850 mg TID Other Names: Initial drug added to non-pharmacological measuresDrug: Glybenclamide 10 mg BID Other Names: Second oral agent to be addedDrug: NPH insulin Variable SC dose Other Names: Insulin added to or substituted for OADrug: Hydrochlorothiazide 25 mg QD introduced as initial therapy for hypertension Other Names: Inital RX for hypertensionDrug: Propranolol 40 mg BID Other Names: Introduced if diuretic + captopril do not control BPDrug: Captopril 50 mg TID Other Names: Added to hydrochlorothiazide if BP not attainedDrug: Amlodipine 10 mg QD Other Names: Added to previous if BP control BP not satisfactory
Study Arm (s)	Treatment 124 patients attending the primary care unit included after formal consent.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	124
Estimated Completion Date	July 2012
Estimated Primary Completion Date	January 2012
Eligibility Criteria	Inclusion Criteria: - Type 2 diabetes mellitus (WHO) Exclusion Criteria: - Terminal disease (renal, cancer, heart failure)
Gender	Both
Ages	30 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Brazil

Administrative Information[ + expand ][ + ]

NCT Number	NCT00935805
Other Study ID Numbers	06260
Has Data Monitoring Committee	No
Information Provided By	Hospital de Clinicas de Porto Alegre
Study Sponsor	Hospital de Clinicas de Porto Alegre
Collaborators	Conselho Nacional de Desenvolvimento Científico e Tecnológico Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Investigators	Principal Investigator: Rogerio Friedman, MD, PhD Hospital de Clinicas de Porto AlegreStudy Chair: Jorge L Gross, MD, PhD Hospital de Clinicas de Porto Alegre
Verification Date	July 2011

Locations[ + expand ][ + ]