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

Imperial College London Diabetes Centre

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT02413762

IREC019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,512 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• all

Exclusion criteria

• lack of capacity for informed consent; vulnerable individuals

Trial design

1,512 participants in 5 patient groups

NGT, no insulin resistance

Description:

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

IFG/IGT/T2DM

Description:

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

Insulin resistance without IGT

Description:

e.g. polycystic ovarian syndrome. No intervention.

IGT, no insulin resistance

Description:

e.g. T1DM. No intervention.

Previous metabolic surgery

Description:

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

Treatment:

Other: No intervention