Diabetes Mellitus, Type 2
Conditions
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.
Interventions
OTHERNo intervention
No intervention
Sponsors
Imperial College London Diabetes Centre
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* all
Exclusion criteria
* lack of capacity for informed consent; vulnerable individuals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Progression to NAFLD or NASH | 5 years | As defined by ultrasound criteria of NAFLD or evidence of fibrosis as measured using transient elastography, respectively |
Countries
United Arab Emirates
Outcome results
None listed