Effect of integrated care services on glycemic control and cardiovascular risk factors

The impact of integrated care program on glycemic control and cardiovascular risk factors in adults patients with type 2 diabetes at Al-Wazarat Healthcare Center (WHC) in Saudi Arabia: an interventional parallel-group controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN83437562

Enrollment

263

Registered

2016-09-19

Start date

2014-02-28

Completion date

Unknown

Last updated

2018-02-26

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

Conditions

Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus

Interventions

264 poorly controlled type 2 diabetes patients were randomly assigned to either a control or intervention group. The control group consists of patients who received standard medical care. The patien

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 and older 2. Diagnosed with Type 2 Diabetes Mellitus 3. Receiving care at the WHC 4. Had at least two clinic visits before the study 5. Can provide informed consent 6. Poor glycemic control (HbA1c level >10) (86 mmol/mol) or persistent elevation of HbA1c >8 (64 mmol/mol) for one year or more) 7. Failure to respond to therapeutic insulin dose of > 2 units/kg or 200 units irrespective of weight 8. Inadequate adherence to insulin 9. Uncontrolled hypertension or hyperlipidemia with a maximum possible combination of medications 10. Comorbidity such as cardiovascular, renal, or hepatic disease 11. Inadequate continuity of care (such as recurrent missed appointment for insulin titration)

Exclusion criteria

Exclusion criteria: 1. Type 1 Diabetes Mellitus (these patients receive care from the Endocrinology department which will compromise the standardized level of care 2. Type 2 Diabetes Mellitus patients who receive care from Endocrinology department or other departments 3. Patients younger than 18 years old 4. Patients who cannot provide informed consent

Design outcomes

Primary

Measure	Time frame
1. Glycated hemoglobin (HbA1c), measured from blood samples taken at baseline, 3, 6 and 9 months. 2. Lipid profile (HDL-cholesterol, LDL-cholesterol, Triglycerides), measured using commercial equipment (Dimension®, Dade Behring, Germany) at baseline, 3, 6 and 9 months	—

Secondary

Measure	Time frame
1. Fasting plasma glucose (FPG), measured using the fasting plasma glucose test using blood samples taken at baseline, 3 months, 6 months, and 9 months 2. Blood pressure, measured using a validated automatic sphygmomanometer (OMRON M4-I) when the participant is in a sitting position (weekly measurement for 9 months) 3. Weight measured in kg on a scale 4. BMI, calculated as the ratio between weight and height (kg/m2) at baseline, and 9 months 5. Serum cardiac troponin T (cTnT) and Creatine Kinase MB Isoenzyme (CK-MB), from blood taken at baseline, 3, 6, and 9 months	—

Measure

Time frame

1. Fasting plasma glucose (FPG), measured using the fasting plasma glucose test using blood samples taken at baseline, 3 months, 6 months, and 9 months 2. Blood pressure, measured using a validated automatic sphygmomanometer (OMRON M4-I) when the participant is in a sitting position (weekly measurement for 9 months) 3. Weight measured in kg on a scale 4. BMI, calculated as the ratio between weight and height (kg/m2) at baseline, and 9 months 5. Serum cardiac troponin T (cTnT) and Creatine Kinase MB Isoenzyme (CK-MB), from blood taken at baseline, 3, 6, and 9 months

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Countries

Saudi Arabia

Contacts

Public ContactAyla Tourkmani

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026