Pancreatogenic Diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
There will be three interventions, all delivered as single subcutaneous injections:
1. 0.9% saline placebo.
2. Pancreatic polypeptide analogue PP 1420, 2 mg.
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 2. Diagnosed with pancreatogenic diabetes (PD) on the basis of: 2.1. WHO 2006 and 2011 criteria defining diabetes mellitus: fasting plasma glucose of =7.0 mmol/L, 2-hour plasma glucose of =11.1 mmol/L after a 75g oral glucose load is consumed, and/or HbA1c =48 mmol/mol. 2.2. Evidence of pancreatic exocrine deficiency: faecal pancreatic elastase levels below local reference limits. 2.3. Abnormal pancreatic morphology on imaging by CT, ultrasound or MRI scanning. 2.4. No evidence of diabetic autoimmune disease, e.g. negative anti-glutamic acid decarboxylase antibodies 2.5. Deficient PP response to a mixed meal tolerance test (<2-fold elevation in PP levels from baseline to peak). 3. Treated with insulin or oral hypoglycaemics for diabetes, doses stable (less than ±10% change in previous 3 months)
Exclusion criteria
Exclusion criteria: Current pregnancy (positive urinary ß-hCG test)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepatic insulin resistance will be measured using endogenous glucose production as assessed during an euglycaemic hyperinsulinaemic clamp commenced 120 mins before the intervention is given. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Peripheral insulin resistance will be measured using the following parameters as assessed during an euglycaemic hyperinsulinaemic clamp commenced 120 mins before the intervention is given: 1.1. Glucose uptake (Rd) 1.2. Metabolic clearance rate (MCR) | — |
Countries
United Kingdom
Outcome results
None listed