Investigating whether blocking intestinal sweet taste sensing alters blood glucose control in adults with type 2 diabetes

Not Applicable

• Conditions: Type 2 Diabetes Mellitus; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12621000981820
• Lead Sponsor: Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-26
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

i) Volunteers with Type 2 Diabetes Mellitus (American Diabetes Association criteria) managed by metformin alone (morning dose of metformin will be withheld until after study day lunch on each visit, to reduce effects on gut hormone responses)
ii) HbA1c less than or equal to 8.5%
iii) Body mass index (BMI) 25 - 35 kg/m2
iv) Haemoglobin above the lower limit of the normal range (i.e. above 135g/L for men and above 115g/L for women), and ferritin above the lower limit of normal (above 20ng/mL for women and above 30ng/mL for men)
v) Consumption of more than one low-calorie sweetener (LCS) containing beverage per day, or equivalent

Exclusion Criteria

i) Significant illness, other than type 2 diabetes, including impairment to cardiovascular or respiratory function that limits a participant’s activity and represents a risk to safe placement of a nasoenteral catheter.
ii) History of gastrointestinal disease, including significant upper gastrointestinal symptoms (assessed by validated gastrointestinal symptom questionnaire), pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendectomy or cholecystectomy)
iii) Impaired renal or liver function (as assessed by calculated creatinine clearance less than or equal to 90 mL/min or abnormal liver function tests (greater than or equal to 2 times upper limit of normal))
iv) Participants medicated with anti-diabetics other than metformin
v) Participants unable to self-monitor blood glucose levels
vi) Volunteers with body mass index greater than or equal to 20 kg/m2 or less than or equal to 35 kg/m2
vii) Donation of blood within the previous 3 months
viii) Participation in any other research studies within the previous 3 months
ix) Participants medicated with opiates, anticholinergics, levodopa, clonidine, nitrates, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, cisapride, prucalopride, or erythromycin
x) Evidence of drug abuse, daily consumption of more than 20 g alcohol or 10 cigarettes
xi) Female patients not using appropriate contraceptive method (i.e. oral contraceptive pill, diaphragm, DepoProvera hormonal contraceptive injection, intrauterine device, Norplant method)
xii) Vegetarian, lactation, or pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified