Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/10/2007
Date assigned
04/12/2007
Last edited
04/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alfonso Calle Pascual

ORCID ID

Contact details

c/o Prof Martin Lagos s/n
Madrid
28040
Spain
+34 913303281
acalle.hcsc@salud.madrid.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

The study was conducted in accordance with the Declaration of Helsinki and approved by the St Carlos University Hospital ethic committee in January 2003.

Study design

Single centre, prospective over 60-months period, interventional and randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/2003

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

126

Participant exclusion criteria

1. Diabetic patients without peripheral vascular disease
2. Younger than 18 years old or older than 85 years old

Recruitment start date

01/01/2003

Recruitment end date

01/01/2008

Locations

Countries of recruitment

Spain

Trial participating centre

c/o Prof Martin Lagos s/n
Madrid
28040
Spain

Sponsor information

Organisation

St Carlos Hospital (Hospital Clínico San Carlos), Department of Endocrinology and Nutrition (Spain)

Sponsor details

c/o Prof Martin Lagos s/n
Madrid
28040
Spain
+34 913303281
pmarroj@hotmail.com

Sponsor type

Hospital/treatment centre

Website

http://www.hcsc.es/

Funders

Funder type

Hospital/treatment centre

Funder name

St Carlos Hospital (Hospital Clinico San Carlos) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes