Does stimulation of gastrointestinal bitter taste receptors reduce energy intake and improve postprandial glycaemia in type 2 diabetes?

Phase 1

Completed

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

• Registration Number: ACTRN12618001764224
• Lead Sponsor: niversity of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-26
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Type 2 diabetes (World Health Organisation (WHO) criteria), managed by diet or metformin only
Body mass index (BMI) from 20 to 40 kg/m2
Age from 50 to 75 years
Males and post-menopausal females
Glycated haemoglobin (HbA1c) equal to 8.5%
Haemoglobin above the lower limit of the normal range (ie. greater 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 greater than 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, 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 less than 90 mL/min or abnormal liver function tests (more than 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