Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/04/2010
Date assigned
12/05/2010
Last edited
16/02/2011
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

Prof Stephen L Atkin

ORCID ID

Contact details

220 - 226 Anlaby Road
Hull
HU3 2RW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

08/H1304/114

Study information

Scientific title

The effect on HbA1c in patients with diabetes mellitus when receiving either intravenous or erythropoietin stimulating agent therapy: a prospective follow-up study

Acronym

Study hypothesis

The fall in HbA1c seen in patients with diabetes mellitus upon receiving either intravenous or erythropoietin stimulating agent therapy is independent of any change in glycaemic control.

Ethics approval

Hull and East Riding Local Research Ethics Committee Research Ethics Office approved on the 16th January 2009 (ref: 08/H1304/114)

Study design

Prospective follow up study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Diabetes mellitus/chronic kidney disease

Intervention

This was a prospective study of patients with T2DM and CKD stage IIIB or IV (estimated glomerular filtration rate MDRD 15 - 44 ml/min/1.73 m^2) selected for treatment with intravenous iron and/or erythropoietin stimulating agents between January 2009 and December 2009 inclusive. All patients were attending a single renal service where the decision to commence iron and ESA therapy was made by the attending physician.

The study consisted of two groups. The first group (A) were patients selected for iron therapy according to clinical need and the second group (B) of patients were those needing ESA treatment.

Iron Therapy Group (A):
All patients selected for iron therapy had either absolute or functional iron deficiency as evidenced by serum ferritin values less than 200 µg/L. All patients had haemoglobin less than or equal to 10.5 g/dl. Patients in this group were not on previous or concurrent ESA therapy and were vitamin B12 and folate replete.

Erythropoietin stimulating agent (ESA) therapy Group (B):
All patients receiving ESA therapy had haemoglobin less than or equal to 10.5 g/dl and were considered iron, vitamin B12 and folate replete prior to initiation. Patients were considered iron replete following a serum ferritin value greater than 200 µg/L or having received intravenous iron at least 6 weeks prior to ESA therapy.

Sample analysis and monitoring of glycaemic control:
Patients in groups A and B were provided with the Abbott Freestyle Freedom Lite glucose sensor (Abbott Diagnostics, Maidenhead, UK). Patients were requested to perform 7 point glucose monitoring (7PGM) 3 times weekly one month before commencement of treatment until the end of the study. 7PGM was defined as pre-meal, 90 min post-meal and pre-bed capillary glucose measurements.

Continuous glucose monitoring (CGMS) was performed using the Medtronic CGMS Ipro Continuous Glucose Recorder (Medtronic Minimed, Northridge, US). Using this system, measurements of interstitial glucose levels were made 228 times over a 24 hour period. This was done in parallel with patient 7PGM over the period of CGMS to allow accurate correlation of glycaemic control. All patients had CGMS performed for at least 2 days prior to ESA therapy and once again at the end of the study.

Results from the 7PGM and CGMS were downloaded from their respective meters for data analysis. Results from the CGMS included at least a successful 24 hour profile over the monitoring period with no gaps greater than 120 mins.

The management of diabetes control were left to the patients and their health care professional. Treatment for glycaemic control was monitored throughout the study period.

Blood was drawn fasting from all patients for HbA1c and full blood profile. Patients in group A and B had samples taken at the one month before commencement of therapy and once again 4 months following treatment initiation.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To study HbA1c changes in relation to mean blood glucose over study period, measured 1 month before treatment initiation and 4 months after.

Secondary outcome measures

Measured 1 month before treatment initiation and 4 months after:
1. To study HbA1c changes in relation to haemoglobin and haematocrit levels
2. To relate fructosamine, glycated albumin and 1,5 anhydroglucitol with changes in mean blood glucose

Overall trial start date

01/02/2009

Overall trial end date

01/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with established chronic kidney disease (stage III - IV) (estimated glomerular filtration rate [eGFR] using Modification of Diet in Renal Disease [MDRD] 15 - 59 mL/min/1.73 m^2) who are to undergo iron and/or erythropoiesis stimulating agent (ESA) therapy
2. Patients who have established diabetes mellitus - both type I and II
3. Patients with no prior diagnosis of diabetes mellitus (control group)
4. Aged 18 to 80 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Patients who not have renal failure (CKD stage I and II)
2. Patients who are unable or do not wish to give consent
3. Patients with currently investigated for potential blood loss
4. Patients with a haematological malignancy/haemolysis
5. Patients with known haemaglobinopathy
6. Patient with significant liver disease (prothrombin time [PT] greater than 16)
7. Patients with a diagnosis of myeloma
8. Patients with severe hyperparathyroidism (parathyroid hormone [PTH] greater than 800 picograms/ml)

Recruitment start date

01/02/2009

Recruitment end date

01/06/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

220 - 226 Anlaby Road
Hull
HU3 2RW
United Kingdom

Sponsor information

Organisation

Hull and East Yorkshire Hospitals NHS Trust (UK)

Sponsor details

Medical Research
Teaching and Day Surgery Building
Daisy Building
Castle Hill Hospital
Castle Road
Hull
HU16 5JQ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.hey.nhs.uk

Funders

Funder type

University/education

Funder name

Hull York Medical School (UK) - Michael White Research Department

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

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20798337

Publication citations

  1. Results

    Ng JM, Cooke M, Bhandari S, Atkin SL, Kilpatrick ES, The effect of iron and erythropoietin treatment on the A1C of patients with diabetes and chronic kidney disease., Diabetes Care, 2010, 33, 11, 2310-2313, doi: 10.2337/dc10-0917.

Additional files

Editorial Notes