The Role of Gut Hormones and Hepcidin in Type 2 Diabetes Mellitus
NCT ID: NCT02413762
Last Updated: 2023-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1512 participants
OBSERVATIONAL
2015-03-31
2022-10-31
Brief Summary
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Detailed Description
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Serum pancreatic polypeptide levels correlate with visceral adiposity and may therefore contribute to the diagnosis of, and risk stratification in, the metabolic syndrome.
Hypothesis:
Measuring iron status, incretin hormones and serum pancreatic polypeptide will facilitate discrimination of patients at risk of vascular complications of T2DM and clinically significant non-alcoholic fatty liver disease.
Statistical analysis:
Serum/plasma level of hormone under investigation corrected for age, sex, BMI, diabetes duration, blood pressure, lipid profile, smoking status, treatment for diabetes, hypertension and dyslipidaemia, and HbA1c using multinomial logistic regression and Cox regression models.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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NGT, no insulin resistance
Individuals with normal glucose tolerance without a diagnosis of IGF, IGT or Diabetes Mellitus. No intervention.
No interventions assigned to this group
IFG/IGT/T2DM
Individuals with a diagnosis of impaired glucose tolerance, impaired fasting glucose or type 2 diabetes mellitus. No intervention.
No interventions assigned to this group
Insulin resistance without IGT
e.g. polycystic ovarian syndrome. No intervention.
No interventions assigned to this group
IGT, no insulin resistance
e.g. T1DM. No intervention.
No interventions assigned to this group
Previous metabolic surgery
Previous metabolic surgery for weight loss or treatment of T2DM. No intervention.
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Imperial College London Diabetes Centre
OTHER
Responsible Party
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Principal Investigators
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Nader Lessan, MBBS FRCP MD
Role: PRINCIPAL_INVESTIGATOR
Imperial College London Diabetes Centre
Locations
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Imperial College London Diabetes Centre
Abu Dhabi, , United Arab Emirates
Countries
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References
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Sam AH, Sleeth ML, Thomas EL, Ismail NA, Mat Daud N, Chambers E, Shojaee-Moradie F, Umpleby M, Goldstone AP, Le Roux CW, Bech P, Busbridge M, Laurie R, Cuthbertson DJ, Buckley A, Ghatei MA, Bloom SR, Frost GS, Bell JD, Murphy KG. Circulating pancreatic polypeptide concentrations predict visceral and liver fat content. J Clin Endocrinol Metab. 2015 Mar;100(3):1048-52. doi: 10.1210/jc.2014-3450. Epub 2014 Dec 9.
Sam AH, Busbridge M, Amin A, Webber L, White D, Franks S, Martin NM, Sleeth M, Ismail NA, Daud NM, Papamargaritis D, Le Roux CW, Chapman RS, Frost G, Bloom SR, Murphy KG. Hepcidin levels in diabetes mellitus and polycystic ovary syndrome. Diabet Med. 2013 Dec;30(12):1495-9. doi: 10.1111/dme.12262. Epub 2013 Aug 19.
Fleming RE. Iron and inflammation: cross-talk between pathways regulating hepcidin. J Mol Med (Berl). 2008 May;86(5):491-4. doi: 10.1007/s00109-008-0349-8. No abstract available.
Fargion S, Dongiovanni P, Guzzo A, Colombo S, Valenti L, Fracanzani AL. Iron and insulin resistance. Aliment Pharmacol Ther. 2005 Nov;22 Suppl 2:61-3. doi: 10.1111/j.1365-2036.2005.02599.x.
Semple RK, Sleigh A, Murgatroyd PR, Adams CA, Bluck L, Jackson S, Vottero A, Kanabar D, Charlton-Menys V, Durrington P, Soos MA, Carpenter TA, Lomas DJ, Cochran EK, Gorden P, O'Rahilly S, Savage DB. Postreceptor insulin resistance contributes to human dyslipidemia and hepatic steatosis. J Clin Invest. 2009 Feb;119(2):315-22. doi: 10.1172/JCI37432. Epub 2009 Jan 26.
Other Identifiers
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IREC019
Identifier Type: -
Identifier Source: org_study_id
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