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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: No intervention

• Registration Number: NCT02413762
• Lead Sponsor: Imperial College London Diabetes Centre

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-07
• Study First Submitted QC: 2015-04-07
• Study First Posted: 2015-04-10
• Primary Completion: 2017-08
• Study Completion: 2022-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-29
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1512

Inclusion Criteria

• all

Exclusion Criteria

• lack of capacity for informed consent; vulnerable individuals

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Microvascular complication of diabetes mellitus - prevalence and incidence	5 years	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.
Macrovascular complication of diabetes mellitus - prevalence and incidence	5 years	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.

Secondary Outcome Measures

Name	Time	Method
Progression to NAFLD or NASH	5 years	As defined by ultrasound criteria of NAFLD or evidence of fibrosis as measured using transient elastography, respectively

Trial Locations

Locations (1)

Imperial College London Diabetes Centre; 🇦🇪 Abu Dhabi, United Arab Emirates