Acute effect of the renally excreted low-calorie sweetener, acesulfame potassium (Ace-K), on urinary glucose excretion in people with type 2 diabetes.

Not Applicable

Active, not recruiting

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

• Registration Number: ACTRN12623000094673
• Lead Sponsor: The University of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-27
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Type 2 diabetes (American Diabetes Association criteria) treated by diet and/or one or two oral glucose-lowering agents (on stable doses over the last 3 months) except for SGLT2 inhibitors
- Body mass index (BMI) from 20 to 40 kg/m2, and body weight over 70 kg
- Males and females, aged from 40 to 79 years
- Glycated haemoglobin (HbA1c) above 6.0%, but less than 7.9%
- Haemoglobin above the lower limit of the normal range (ie. above 135g/L for men and 115g/L for women), and ferritin above the lower limit of normal (ie. above 30ng/mL for men and above 20mg/mL for women)

Exclusion Criteria

- Habitual use of more than one serve of any food or beverage containing a LCS per day during the past 3 months, ascertained using a LCS frequency questionnaire.
- Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis
- History of any form of heart disease or symptoms of syncope or pre-syncope (including feeling lightheaded or dizzy, feeling unsteady when standing, unexplained falls, fainting, unexplained changes in vision, such as blurring or tunnel vision)
- Other significant illness, including epilepsy, cardiovascular or respiratory disease
- Impaired renal or liver function (as assessed by calculated creatinine clearance less than 60 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
- Inability to give informed consent
- Vegetarians

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference in accumulated urinary glucose excretion (= urine glucose concentrations * urine volume) between Ace-K, sucralose and placebo days.[ t = 30, 90, 150 and 210 min, where t = 0 is when glucose clamping starts and t = 30 is when first dose of Ace-k/sucralose/placebo is given, on three study days.]

Secondary Outcome Measures

Name	Time	Method
The difference in estimated renal glucose reabsorption (plasma glucose levels * glomerular filtration rate * 180min - accumulated urinary glucose excretion from t = 30 to 210min) between Ace-K, sucralose and placebo days.[ t = 30, 90, 150 and 210 min, where t = 0 is when glucose clamping starts and t = 30 is when the first dose of Ace-k/sucralose/placebo is given, on three study days.];The difference in the amount of glucose infused intravenously (quantified by the infusion pump) to maintain the hyperglycaemic clamp between Ace-K, sucralose and placebo days.[ Placebo visit, Ace-K visit and sucralose visit];The difference in plasma insulin levels between Ace-K, sucralose and placebo days.[ where t = 0 is when glucose clamping starts and t = 30 is when the first dose of Ace-k/sucralose/placebo is given, on three study days.]