Medication, Education and Medication Optimisation: improving glycaemic control and blood pressure in patients with microalbuminuria from a mixed ethnic population

Integrated care-based education intervention to improve glycaemic control and blood pressure in patients with microalbuminuria from a mixed ethnic population: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN83140074

Enrollment

189

Registered

2009-03-30

Start date

2005-09-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus/nephropathy Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

Intervention arm: Participants attend group education sessions. Initially they are offered a basic programme of 6 hours around basic diabetes. They then attend a 3-hour session on diabetes and the k

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Aged 25 - 80 years, either sex 2. A confirmed diagnosis of type 2 diabetes on diet, tablets or insulin 3. Microalbuminuria or proteinuria

Exclusion criteria

Exclusion criteria: 1. A malignancy 2. Liver disease 3. An autoimmune disease 4. Any life threatening condition with a life expectancy of less than 5 years 5. Immobility (difficult to attend sessions) 6. Learning disability or mental incapacity 7. Serum creatinine greater than 180 µmol/l 8. Patients taking part in another research study

Design outcomes

Primary

Measure	Time frame
HbA1c at 18 months.	—

Secondary

Measure	Time frame
1. Cardiovascular events at 4 years 2. Mortality at 4 years 3. Biochemical measured at baseline and 6, 12, 18, 24, 36, 48 months 4. Blood pressure measured at baseline and 6, 12, 18, 24, 36, 48 months 5. Blood lipids measured at baseline and 6, 12, 18, 24, 36, 48 months 6. HbA1c measured at baseline and 6, 12, 18, 24, 36, 48 months 7. Medication use measured at baseline and 6, 12, 18, 24, 36, 48 months 8. Urinary albumin excretion measured at baseline and 18, 24, 36 and 48 months 9. Serum creatinine and urea levels measured at baseline and 6, 12, 18, 24, 36, 48 months 10. Smoking status measured at baseline and 6, 12, 18, 24, 36, 48 months 11. Physical activity measured at baseline and 6, 12, 18, 24, 36, 48 months 12. Quality of life measured at baseline and 6, 12, 18, 24, 36, 48 months 13. Medication beliefs measured at baseline and 6, 12, 18, 24, 36, 48 months 14. Depression measured at baseline and 6, 12, 18, 24, 36, 48 months 15. Personality measured at baseline	—

Measure

Time frame

1. Cardiovascular events at 4 years 2. Mortality at 4 years 3. Biochemical measured at baseline and 6, 12, 18, 24, 36, 48 months 4. Blood pressure measured at baseline and 6, 12, 18, 24, 36, 48 months 5. Blood lipids measured at baseline and 6, 12, 18, 24, 36, 48 months 6. HbA1c measured at baseline and 6, 12, 18, 24, 36, 48 months 7. Medication use measured at baseline and 6, 12, 18, 24, 36, 48 months 8. Urinary albumin excretion measured at baseline and 18, 24, 36 and 48 months 9. Serum creatinine and urea levels measured at baseline and 6, 12, 18, 24, 36, 48 months 10. Smoking status measured at baseline and 6, 12, 18, 24, 36, 48 months 11. Physical activity measured at baseline and 6, 12, 18, 24, 36, 48 months 12. Quality of life measured at baseline and 6, 12, 18, 24, 36, 48 months 13. Medication beliefs measured at baseline and 6, 12, 18, 24, 36, 48 months 14. Depression measured at baseline and 6, 12, 18, 24, 36, 48 months 15. Personality measured at baseline

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026