Effects of the non-nutritive bitter taste flavouring, denatonium benzoate (DB), and the low-nutritive bitter taste amino acid, leucine, on gastrointestinal hormone secretion and energy intake in health and type 2 diabetes – regional differences in small intestinal exposure.

Not Applicable

Not yet recruiting

Conditions: Type 2 diabetes mellitus
obesity
Metabolic and Endocrine - Diabetes
Metabolic and Endocrine - Normal metabolism and endocrine development and function
Diet and Nutrition - Obesity

Registration Number: ACTRN12618001747213

Lead Sponsor: niversity of Adelaide

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not yet recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Patients with type 2 diabetes (World Health Organisation (WHO) criteria), HbA1c less than or equal to 8.5%, managed by diet or metformin alone, body mass index 20-35 kg/m2, both males and females aged 18-75 years.

Healthy volunteers, matched as closely as possible to the diabetic subjects for age, sex, and BMI.

Additional inclusion criteria include: haemoglobin above the lower limit of the normal range (ie. more than 135g/L for men and 115g/L for women), and ferritin above the lower limit of normal (ie. more than 30ng/mL for men and more than 20mg/mL for women)

Exclusion Criteria

Use of any medication that may influence 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
Inability to give informed consent
Female participants who are pregnant or planning for pregnancy, or are lactating
Vegetarians

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
differences in the incremental area under the curve (iAUC) for plasma GLP-1 between the treatments[t = 0, 15, 30, 45 and 60 min where t=0 is when infusion started.]

Secondary Outcome Measures

Name	Time	Method
differences in energy intake from a standardised cold buffet meal between the 5 treatments are assessed by weighing each food item before and after consumption. The amount of energy intake is calculated using Foodworks 3.01 (Xyris Software, Highgate Hill, QLD, Australia).[t= 90min where t=0 is when rectal infusion started.];differences in the incremental area under the curve (iAUC) for plasma PYY between the treatments[t = 0, 15, 30, 45 and 60 min where t=0 is when infusion started.];differences in the incremental area under the curve (iAUC) for glucose, assessed by plasma assay, between the treatments[t = 0, 15, 30, 45 and 60 min where t=0 is when infusion started.];differences in the incremental area under the curve (iAUC) for gastrointestinal sensations, assessed by validated visual analogue scales, between the 5 treatments.[t = 0, 15, 30, 45 and 60 min where t=0 is when infusion started.]