NCT02413762

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,512

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 7, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

2.4 years

First QC Date

April 7, 2015

Last Update Submit

May 29, 2023

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • Microvascular complication of diabetes mellitus - prevalence and incidence

    Prevalence at enrolment and subsequent incidence of background diabetic retinopathy, preproliferative or proliferative retinopathy, or diabetic maculopathy; microalbuminuria defined as two episodes \> 3 months apart of ACR \> 2.5 (male) or \> 3.5 (female) mg/umol. Assessed through patient recall and examination of electronic medical record.

    5 years

  • Macrovascular complication of diabetes mellitus - prevalence and incidence

    Prevalence at enrolment and subsequent incidence of composite endpoint of coronary artery disease (MI, ACS, percutaneous intervention), cerebrovascular disease (CVA, TIA), and peripheral arterial disease (ischaemic peripheral ulcer, revascularisation procedure, amputation). Assessed through patient recall and examination of electronic medical record.

    5 years

Secondary Outcomes (1)

  • Progression to NAFLD or NASH

    5 years

Study Arms (5)

NGT, no insulin resistance

Individuals with normal glucose tolerance without a diagnosis of IGF, IGT or Diabetes Mellitus. No intervention.

IFG/IGT/T2DM

Individuals with a diagnosis of impaired glucose tolerance, impaired fasting glucose or type 2 diabetes mellitus. No intervention.

Insulin resistance without IGT

e.g. polycystic ovarian syndrome. No intervention.

IGT, no insulin resistance

e.g. T1DM. No intervention.

Previous metabolic surgery

Previous metabolic surgery for weight loss or treatment of T2DM. No intervention.

Other: No intervention

Interventions

No interventionOTHER

No intervention

Previous metabolic surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults resident in the UAE, attending ICLDC for normal healthcare.

You may qualify if:

  • all

You may not qualify if:

  • lack of capacity for informed consent; vulnerable individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London Diabetes Centre

Abu Dhabi, 48338, United Arab Emirates

Location

Related Publications (5)

  • 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.

    PMID: 25490276BACKGROUND

  • 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.

    PMID: 23796160BACKGROUND

  • 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.

    PMID: 18425494BACKGROUND

  • 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.

    PMID: 16225476BACKGROUND

  • 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.

    PMID: 19164855BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Nader Lessan, MBBS FRCP MD

    Imperial College London Diabetes Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2015

First Posted

April 10, 2015

Study Start

March 1, 2015

Primary Completion

August 1, 2017

Study Completion

October 1, 2022

Last Updated

June 1, 2023

Record last verified: 2023-05

Locations

AE(1)