GRETEL - GastRic EmpTying acceleration after fast and slow hypoglycaEmic cLamp

Phase 1

Recruiting

• Conditions: type 1 diabetes; delayed gastric emptying; Metabolic and Endocrine - Diabetes; Metabolic and Endocrine - Normal metabolism and endocrine development and function

• Registration Number: ACTRN12623001226695
• Lead Sponsor: Central Adelaide Health Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-28
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Men and women with type 1 diabetes
Aged 18 years and over
HbA 1c lesser than or equal to 9.5 %

Exclusion Criteria

• History of type 2 diabetes
• HbA 1c greater than 9.5 %
• History of gastrointestinal disease, including known gastroparesis, peptic
ulcer disease, significant upper or lower gastrointestinal symptoms, or
previous gastrointestinal surgery (other than uncomplicated
appendicectomy or cholecystectomy) or a history of migraine or panic
attacks.
• Other significant illness, including epilepsy, cardiovascular or respiratory
disease.
• Chronic Kidney Disease (CKD) 4-5 (eGFR less than 30) or if iron stores or liver function tests are outside the
following normal ranges:
- Haemoglobin 130 – 180 g/L (Males)
- Haemoglobin 115 – 155 g/L (Females)
- Ferritin less than 30 µg/L (Males)
- Ferritin less than 15µg/L(Females)
• Requirement for medication known to influence gastrointestinal function,
(e.g. prokinetic drugs [metoclopramide, domperidone, erythromycin],
antiemetics [ondansetron], antidiarrhoeals [loperamide], H 2 receptor
antagonists [ranitidine], drugs with substantial anticholinergic effects
[amitriptyline, doxepin, dothiepin, mirtazapine, haloperidol,
chlorpromazine, risperidone, oxybutynin], opioids [morphine, oxycodone,
codeine], orlistat.
• Evidence of drug or alcohol abuse, or consumption of more than 20 g
alcohol or 10 cigarettes on a daily basis.
• Donation of blood within the previous 3 months
• Participation in any other research studies within the previous 3 months
• Previous exposure to radiation for research purposes in the preceding 12
months
• Inability to give informed consent
• Positive pregnancy status or lactating (breast-feeding) female
• Vegetarian or vegan

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastric emptying[Scintigraphy Scintigraphy will commence at the onset of hypoglycaemia (2.8mmol/L) and will continue for up to 60 minutes after ingestion of a standardised meal labelled with a radiotracer. Scintigraphy will commence 2 hours after study commencement for the slow hypoglycaemia and euglycaemia arms, and 15 minutes after the fast hypoglycaemia arm.]