The effect of the glucagon-like peptide-1 analogue, exenatide, on duodenal motility and flow events, and small intestinal transit in healthy humans and type 2 diabetes mellitus.

Phase 1

Completed

• Conditions: Type 2 diabetes; Small intestinal motility; Glucose absorption; Metabolic and Endocrine - Diabetes; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12608000428369
• Lead Sponsor: Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Healthy subjects:
1. Body mass index (BMI) 19 - 25 kg/m2
Type 2 diabetic patients:
1. Body mass index (BMI) 19 - 35 kg/m2
2. Type 2 diabetes (World Health Organisation (WHO) criteria) managed by diet alone (i.e no oral hypoglycaemic drugs or insulin)

Exclusion Criteria

History of gastrointestinal surgery (except appendicectomy)
1. Medication which may affect gastrointestinal motor function, specifically: opiates, anticholinergics, levodopa, calcium-channel antagonists, beta blockers, clonidine, nitrates, tricyclic antidepressants, selective serotonin re-uptake inhibitors, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, cisapride, tegaserod, erythromycin
2. Other significant illness, including epilepsy, cardiovascular or respiratory disease
3. Pregnancy or lactation
4. Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes per day
5. Regular gastrointestinal symptoms (as assessed by a validated upper gastrointestinal symptom questionnaire)
6. Autonomic nerve damage (as assessed by standardised cardiovascular reflex tests)

Study & Design

• Study Type: Interventional
• Study Design: Not specified