The Role of Gut Hormones and Hepcidin in Type 2 Diabetes Mellitus

NCT ID: NCT02413762

Last Updated: 2023-06-01

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

1512 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2022-10-31

Brief Summary

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This study aims to investigate the potential of the gut hormones GLP-1, PP, PYY and the iron regulatory hormone hepcidin as biomarkers for progression to complications in diabetes mellitus.

Detailed Description

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Iron overload and mechanisms inducing insulin resistance are reciprocally linked. Dietary iron absorption, and iron uptake in liver and adipose tissue, are regulated through the hormone hepcidin. Iron is implicated in microvascular and macrovascular disease pathways and therefore hepcidin may represent a biomarker for progression to complications in type 2 diabetes mellitus.

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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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* all

Exclusion Criteria

* lack of capacity for informed consent; vulnerable individuals
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Imperial College London Diabetes Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United Arab Emirates

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.

Reference Type BACKGROUND
PMID: 25490276 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23796160 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18425494 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16225476 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19164855 (View on PubMed)

Other Identifiers

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IREC019

Identifier Type: -

Identifier Source: org_study_id

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