Influence of erythropoietin simulating agents and iron therapy on HbA1c
| ISRCTN | ISRCTN52414847 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52414847 |
| Secondary identifying numbers | 08/H1304/114 |
- Submission date
- 29/04/2010
- Registration date
- 12/05/2010
- Last edited
- 16/02/2011
- 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
Prof Stephen L Atkin
Scientific
Scientific
220 - 226 Anlaby Road
Hull
HU3 2RW
United Kingdom
Study information
| Study design | Prospective follow up study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Hull and East Riding Local Research Ethics Committee Research Ethics Office approved on the 16th January 2009 (ref: 08/H1304/114) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/02/2009 |
| Completion date | 01/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/02/2009 |
| Date of final enrolment | 01/06/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
220 - 226 Anlaby Road
Hull
HU3 2RW
United Kingdom
HU3 2RW
United Kingdom
Sponsor information
Hull and East Yorkshire Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Medical Research, Teaching and Day Surgery Building
Daisy Building
Castle Hill Hospital
Castle Road
Hull
HU16 5JQ
England
United Kingdom
| Website | http://www.hey.nhs.uk |
|---|---|
"ROR" |
https://ror.org/01b11x021 |
Funders
Funder type
University/education
Hull York Medical School (UK) - Michael White Research Department
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 | 01/11/2010 | Yes | No |
