Regional glucose infusion on gut functio

Not Applicable

Completed

• Conditions: Glucose metabolism; Metabolic and Endocrine - Normal metabolism and endocrine development and function; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12615001240538
• 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: 32

Inclusion Criteria

Type 2 diabetic subjects
*Managed by diet alone (i.e. no oral hypoglycaemic drugs or insulin)
*Body mass index (BMI) 20 - 35 kg/m2
*Age 18 - 75 years
*Males and post-menopausal females (to control for the effect of the menstrual cycle on gut hormone secretion)
*Glycated haemoglobin (HbA1c) greater than or equal to 6.0% and less than or equal to 7.9%
*Haemoglobin above the lower limit of the normal range (i.e. >135g/L for men and 115g/L for women), and ferritin above the lower limit of normal (i.e. >10mcg/L)

Healthy subjects
*Male and postmenopausal females aged 18 – 75 years
*Body mass index (BMI) 20 - 35 kg/m2
*Age- and BMI-matched to the diabetic subjects

Exclusion Criteria

*Use of any medication that may influence BP, gastrointestinal motor function, body weight or appetite (e.g. antihypertensive drugs, domperidone and cisapride, anticholinergic drugs (e.g. atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St. John's Wort etc.)
*Evidence of drug abuse, 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
*Vegetarians

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
differences in the iAUC for blood glucose after ID vs. II glucose infusion at 2 kcal/min[at t = 0, 15, 30, 45, 60, 90, 120, 150 and 180 min, where t=0 min is start of glucose administration. ];differences in the iAUC for plasma GLP-1 after ID vs. II glucose infusion at 2 kcal/min[at t = 0, 15, 30, 45, 60, 90, 120, 150 and 180 min, where t=0 min is start of glucose administration. ];differences in the iAUC for plasma GIP after ID vs. II glucose infusion at 2 kcal/min[at t = 0, 15, 30, 45, 60, 90, 120, 150 and 180 min, where t=0 min is start of glucose administration. ]