Diabetes mellitus Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
Participants all have type 1 or type 2 diabetes and will be newly diagnosed with pancreatic exocrine insufficiency. At the first visit, participants fill out a questionnaire about their gastrointestin
Sponsors
Portsmouth Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or Female, aged 18 years or above 2. Diagnosed with Type 1 diabetes or Type 2 diabetes at least 1 year ago, and be receiving oral and / or insulin therapy for diabetes 3. Have 1 or more symptoms of PEI: 3.1. Diarrhoea – Bristol Stool Chart (see appendix) type 5, 6 or 7 3.2. Steatorrhoea or greasy, pale or offensive smelling stools 3.3. Weight loss 3.4. Abdominal pain or cramps 3.5. Bloating or increased flatulence 4. Low faecal elastase level <200mcg/g in last 2 years 5. Willing and able to give informed consent for participation in the study and for GP to be informed
Exclusion criteria
Exclusion criteria: 1. Currently receiving, or have ever received, PERT 2. Current prescription of or planning to commence medication (within next 2 months), other than those for diabetes, that may increase or decrease serum glucose levels such as: 2.1. Oral corticosteroids for more than 7 days 2.2. Antipsychotics 2.3. Nutritional supplements such as Fresubin® 2.4. Weight-loss medication such as orlistat 3. Diagnosed with or suspected diagnosis of: 3.1. Pancreatic malignancy 3.2. Acute pancreatitis or chronic pancreatitis 3.3. Type 3c diabetes or other Type 3 secondary diabetes 3.4. Cystic fibrosis 3.5. Previous or awaited gastric bypass (within next 2 months), pancreatic or extensive small bowel surgery 3.6. Other primary pancreatic disorder or uncontrolled liver disorder (exception: non-alcoholic fatty liver disease) 4. Current or recently resolved (within 2 weeks) acute diarrhoeal episode thought likely to be infectious or other gastroenteritis 5. Current of previous chronic alcohol excess 6. Currently pregnant, recently postpartum (within 6 months) or planning pregnancy before end of study date 7. Currently using a modified diet under dietetic supervision, such as FODMAP 8. Currently receiving supported nutrition, including via nasogastric tube, gastrostomy tube or parenteral nutrition 9. Known allergy to Creon® or any of its components 10. Objection to porcine origin of pancreatin 11. Known allergy to Freestyle Libre Pro adhesive pad 12. Already enrolled, or recently (within 6 weeks) taken part in, another study that may affect glycaemic control or that may affect digestion or absorption or another aspect of the GI system or nutrition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean glucose interquartile range measured over 14 days at baseline (weeks 0-2) and after pancreatic enzyme replacement therapy (PERT) (at weeks 8-10) as measured using the Freestyle Libre Pro flash glucose monitor. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Other ambulatory glucose profile (AGP) metrics averaged over 14 days as measured by the Freestyle Libre flash glucose monitor at weeks 6-8 of PERT therapy: 1.1. Area under the median curve (AUC) 1.2. Median 1.3. Time above target range (above 10mmol/L and above 15mmol/L) 1.4. Time in target range (TIR) (4-10mmol/L) 1.5. Time below target range (below 4mmol/L and below 3mmol/L) 1.6. Median curve instability 1.7. Specific time periods – including pre-prandial and post-prandial 1.8. Estimated HbA1c 2. GI symptoms are measured using a questionnaire at 8 weeks after starting PERT 3. Clinical measurements – HbA1c, weight, BMI are measured using venous blood sampling and physical examination at 8 weeks after starting PERT | — |
Countries
England, United Kingdom
Contacts
Public ContactKatherine Alington
Outcome results
None listed