Family physician and endocrinologist coordination as the basis for diabetes care in clinical practice
| ISRCTN | ISRCTN75037597 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75037597 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/10/2007
- Registration date
- 04/12/2007
- Last edited
- 31/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Alfonso Calle Pascual
Scientific
Scientific
c/o Prof Martin Lagos s/n
Madrid
28040
Spain
| Phone | +34 913303281 |
|---|---|
| acalle.hcsc@salud.madrid.org |
Study information
| Study design | Single centre, prospective over 60-months period, interventional and randomised controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Not Specified |
| Scientific title | Family physician and endocrinologist coordination as the basis for diabetes care in clinical practice |
| Study objectives | To estimate the proportion of Diabetic Patients (DPts) with peripheral vascular disease treated at a primary health care site after an endocrinologist-based intervention, who meet the Adult Treatment Panel III (ATP III) targets of metabolic control, as well as to compare the outcome with the results of the patients treated by endocrinologists. |
| Ethics approval(s) | The study was conducted in accordance with the Declaration of Helsinki and approved by the St Carlos University Hospital ethic committee in January 2003. |
| Health condition(s) or problem(s) studied | Diabetic patients with a peripheral vascular disease |
| Intervention | After a treatment period of 3 months in the Diabetes Unit of the St Carlos Hospital, 63 of the 126 patients were randomly assigned to receive treatment by the family physicians at primary care level and other 63 to receive treatment by the diabetes team at the Endocrinology Service, St Carlos Hospital for 60 months. The patients were periodically followed, at least every 2 to 4 weeks during the early stage of the trial and after each pharmacologic treatment change, and every 6 months until the completion of the follow-up period to measure the following: 1. Body weight (barefoot, with indoor clothes). 2. Waist circumference. 3. Blood pressure with appropriately sized armlet after 3 minutes in a supine position 4. Urine and blood tests. The patients collected three consecutive first-morning urine samples for the analysis of Albumin-Creatinine Ratio (ACR) and attended the laboratory at 8.30 am after 10 h of fasting to obtain a blood sample in order to determine HbA1c (Diabetes Control and Complications Trial [DCCT] standardized), total cholesterol, High Density Lipoproteins (HDL) cholesterol, triglycerides, apolipoprotein A1, apolipoprotein B and lipoprotein (a) levels. 5. Nutritional intervention based on Diabetes Nutrition and Complications Trial (DNCT): PolyUnsaturated Fatty Acids (PUFAs)/Saturated Fatty Acids (SFAs) >0.4 and MonoUnsaturated Fatty Acids (MUFAs)/SFAs >1.4. |
| Intervention type | Other |
| Primary outcome measure | To estimate the proportion of participants who meet the ATP III and Steno-2 targets of metabolic control, and to compare the difference in trial outcome between the two groups. This will be assessed using the measurements described in the "Interventions" field above. |
| Secondary outcome measures | 1. Progression of peripheral vascular disease at 60 months 2. New onset of micro and macrovascular complications associated with poorly controlled diabetes at 60 months 3. Morbidity and mortality at 60 months |
| Overall study start date | 01/01/2003 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 126 |
| Total final enrolment | 126 |
| Key inclusion criteria | Diabetic patients recruited for the foot-care screening programme were tested for peripheral vascular disease and considered eligible when diagnosed. The patients were considered to have a peripheral vascular disease when they had at least one of the following: 1. Patients who underwent a peripheral vascular revascularization at least 6 months ago 2. Patients with previous non-neuropathy foot lesions at least 6 months ago 3. At least one Ankle/Brachial Index (ABI) <0.8 |
| Key exclusion criteria | 1. Diabetic patients without peripheral vascular disease 2. Younger than 18 years old or older than 85 years old |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- Spain
Study participating centre
c/o Prof Martin Lagos s/n
Madrid
28040
Spain
28040
Spain
Sponsor information
St Carlos Hospital (Hospital Clínico San Carlos), Department of Endocrinology and Nutrition (Spain)
Hospital/treatment centre
Hospital/treatment centre
c/o Prof Martin Lagos s/n
Madrid
28040
Spain
| Phone | +34 913303281 |
|---|---|
| pmarroj@hotmail.com | |
| Website | http://www.hcsc.es/ |
"ROR" |
https://ror.org/04d0ybj29 |
Funders
Funder type
Hospital/treatment centre
St Carlos Hospital (Hospital Clinico San Carlos) (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 31/07/2008 | 31/12/2020 | Yes | No |
Editorial Notes
31/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
