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

NCT00935805 | Unknown

• 1 other identifier: 06260
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Arterial Hypertension

Keywords

Diabetes Mellitus; Arterial Hypertension; Treatment; Primary Care

Outcome Measures

Primary Outcomes (2)

• Glycated hemoglobin A1c

  3 months

• Blood pressure

  1 month

Secondary Outcomes (2)

• 24 hr blood glucose profile

  once

• Fasting blood glucose

  3 months

Study Arms (1)

Treatment

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

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

Interventions

Metformin DRUG

850 mg TID

Also known as: Initial drug added to non-pharmacological measures

Treatment

Glybenclamide DRUG

10 mg BID

Also known as: Second oral agent to be added

Treatment

NPH insulin DRUG

Variable SC dose

Also known as: Insulin added to or substituted for OA

Treatment

Hydrochlorothiazide DRUG

25 mg QD introduced as initial therapy for hypertension

Also known as: Inital RX for hypertension

Treatment

Propranolol DRUG

40 mg BID

Also known as: Introduced if diuretic + captopril do not control BP

Treatment

Captopril DRUG

50 mg TID

Also known as: Added to hydrochlorothiazide if BP not attained

Treatment

Amlodipine DRUG

10 mg QD

Also known as: Added to previous if BP control BP not satisfactory

Treatment

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Type 2 diabetic patients attending a primary care outpatient facility

You may qualify if:

• Type 2 diabetes mellitus (WHO)

You may not qualify if:

• Terminal disease (renal, cancer, heart failure)

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension

Interventions

Metformin; Glyburide; Insulin, Isophane; Hydrochlorothiazide; Propranolol; Captopril; Amlodipine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Sulfonylurea Compounds; Urea; Amides; Sulfones; Sulfur Compounds; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorothiazide; Benzothiadiazines; Sulfonamides; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Proline; Imino Acids; Amino Acids, Cyclic; Amino Acids; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Rogerio Friedman, MD, PhD

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

• Jorge L Gross, MD, PhD

  Hospital de Clinicas de Porto Alegre

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 9, 2009
• Study Start: July 1, 2006
• Primary Completion: January 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 26, 2011

Record last verified: 2011-07

Locations

BR (1)