Predicting Response to Incretin Based Agents in Type 2 Diabetes (PRIBA)
Does Urinary C-peptide Creatinine Ratio Predict Response to Incretin Based Agents in Type 2 Diabetes
Type 2 diabetes is a major and rapidly increasing health problem worldwide. Keeping the blood glucose (sugar) from going too high helps prevent complications. Recently a number of new treatments (collectively called 'incretin based' treatments) to lower blood glucose have become available but response is very variable and it is difficult to predict which will work for an individual. The investigators want to see if we can identify whether the new treatments are likely to be effective for an individual patient. Identifying the right treatment would improve control and minimise the side-effects and costs from ineffective treatments. We will collect blood (for measures of blood glucose, insulin secretion and genetics information), urine (for a simple measurement of insulin secretion) and other clinical information (such as weight,age, duration of diabetes and medication) in people who are about to start these new 'incretin based' treatments and assess their response over the first 6 months of treatment. We will analyse this information to see if we can predict treatment response.
Study Hypothesis:
The investigators hypothesise that those who have low insulin secretion, as measured by post meal urine C-peptide Creatinine Ratio or blood C-peptide, will have poor blood glucose response to incretin based treatments.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Bournmouth, Storbritannia, BH7 7DW
- The Royal Bournmouth and Christchurch Hospitals NHS Trust
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Bristol, Storbritannia, BS10 5NB
- North Bristol NHS Trust
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Ipswich, Storbritannia, IP4 5PD
- Ipswich Hospital NHS Trust
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Northampton, Storbritannia, NN15BD
- Northampton General Hospital NHS Trust
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Oxford, Storbritannia, OX3 9DU
- Oxford Radcliffe Hospitals NHS Trust
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Portsmouth, Storbritannia, PO6 3LY
- Portsmouth Hospitals NHS Trust
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Redhill, Storbritannia, RH1 5RH
- Surrey and Sussex Healthcare NHS Trust
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St Leonards-on-Sea, Storbritannia, TN37 7RD
- East Sussex Healthcare NHS Trust
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Stoke on Trent, Storbritannia, ST4 7LN
- University Hospitls North Staffordshire NHS Trust
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Warwick, Storbritannia, CV34 5BW
- South Warwickshire NHS Foundation Trust
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Watford, Storbritannia, WD18 0HB
- West Hertfordshire Hospitals NHS Trust
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Cornwall
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Truro, Cornwall, Storbritannia, TR13HD
- Cornwall and Isles of Scilly NHS Primary Care Trust
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Devon
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Barnstaple, Devon, Storbritannia, EX314JB
- North Devon NHS Trust
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Exeter, Devon, Storbritannia, EX25DW
- Royal Devon and Exeter NHS Foundation Trust
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Plymouth, Devon, Storbritannia, PL68DH
- Plymouth Hospitals NHS Trust
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Torbay, Devon, Storbritannia, TQ27AA
- South Devon Healthcare NHS Foundation Trust
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Somerset
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Taunton, Somerset, Storbritannia, BA228HR
- Taunton and Somerset NHS Foundation Trust.
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Yeovil, Somerset, Storbritannia, BA21 4AT
- Yeovil Disctrict Hospital NHS Foundation Trust
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- A clinical diagnosis of type 2 diabetes mellitus where the patient's clinician has determined the need for a DPP-IV inhibitor or GLP-1 analogue as a result of inadequate glycaemic control
- HbA1c >= 58mmol/mol
Exclusion Criteria:
- Treatment with DPP-IV inhibitors or GLP-1 analogues prior to study initiation (within the previous 3 months)
- Renal failure as shown by a eGFR (estimated glomerular filtration rate) less than 30 mL/min/1.73m2
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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Patients starting incretin treatments
Patients starting GLP-1 agonists or DPPIV inhibitors as part of their normal clinical care.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Glycaemic response (HbA1c change post treatment)
Tidsramme: 6 months
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Change in HbA1c over 6 months treatment (as a continuous variable and/or defined as binary response/non response).
Our Primary analysis will be the relationship between insulin secretion (as measured by blood C-peptide or UCPCR) and glycaemic response.
Secondary analysis will include examination of relationship between baseline weight, HbA1c, age, duration of diabetes, HOMA B, HOMA IR, autoantibody (GAD, IA2) status and glycaemic response.
We will also examine the relationship between glycaemic response and polymorphisms in GLP-1R, TCF7L2, WFS1 and FOX01 genes.
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6 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Weight change over 6 months treatment
Tidsramme: 6 months
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6 months
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Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Andrew T Hattersley, University of Exeter Medical School/Royal Devon and Exeter Hospital NHS Foundation Trust
- Hovedetterforsker: Angus Jones, University of Exeter Medical School/Royal Devon and Exeter Hospital NHS Foundation Trust
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Jones AG, McDonald TJ, Shields BM, Hill AV, Hyde CJ, Knight BA, Hattersley AT; PRIBA Study Group. Markers of beta-Cell Failure Predict Poor Glycemic Response to GLP-1 Receptor Agonist Therapy in Type 2 Diabetes. Diabetes Care. 2016 Feb;39(2):250-7. doi: 10.2337/dc15-0258. Epub 2015 Aug 4.
- Dennis JM, Shields BM, Hill AV, Knight BA, McDonald TJ, Rodgers LR, Weedon MN, Henley WE, Sattar N, Holman RR, Pearson ER, Hattersley AT, Jones AG; MASTERMIND Consortium. Precision Medicine in Type 2 Diabetes: Clinical Markers of Insulin Resistance Are Associated With Altered Short- and Long-term Glycemic Response to DPP-4 Inhibitor Therapy. Diabetes Care. 2018 Apr;41(4):705-712. doi: 10.2337/dc17-1827. Epub 2018 Jan 31.
- Jones AG, Shields BM, Hyde CJ, Henley WE, Hattersley AT. Identifying good responders to glucose lowering therapy in type 2 diabetes: implications for stratified medicine. PLoS One. 2014 Oct 23;9(10):e111235. doi: 10.1371/journal.pone.0111235. eCollection 2014.
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 11233581
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