Bile acids and glycemic control in type 2 diabetes

Phase 1

Completed

• Conditions: Type 2 diabetes mellitus; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12615001239550
• Lead Sponsor: Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

* Type 2 diabetes (World Health Organisation (WHO) criteria), managed by diet or metformin only
* Body mass index (BMI) 20 - 40 kg/m2
* Age 18 - 75 years
* Males and post-menopausal females
* Glycated haemoglobin (HbA1c) less than or equal to 8.5%
* Haemoglobin above the lower limit of the normal range (ie. >135g/L for men and 115g/L for women), and ferritin above the lower limit of normal (ie. >30ng/mL for men and >20mg/mL for women)

Exclusion Criteria

* Use of any medication that may influence gastrointestinal motor function within 48 hours or 5 half lives of the study, specifically: opiates, anticholinergics, levodopa, beta blockers, clonidine, nitrates, tricyclic antidepressants, selective serotonin re-uptake inhibitors, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, cisapride, tegaserod, or erythromycin
* Evidence of drug abuse, or consumption of more than 20 g alcohol or 10 cigarettes on a daily basis
* History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
* Other significant illness, including epilepsy, cardiovascular or respiratory disease
* Impaired renal or liver function (as assessed by calculated creatinine clearance < 90 mL/min or abnormal liver function tests (> 2 times upper limit of normal range))
* Donation of blood within the previous 3 months
* Participation in any other research studies within the previous 3 months
* Females who are pre-menopausal
* Inability to give informed consent
* Participants who do not eat beef
* Vegetarian diet

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the difference in iAUC for blood glucose between treatments[T = -60, -30, 0, 15, 30, 60, 75, 90, 105 and 120 min, where T = -60 min is at start of either iv. exendin(9-39) or 0.9% saline, T = -30 min at start of intrajejunal TCA or saline infusion, and T = 0 min at start of intrajejunal glucose infusion.]