GLY-200 for Duodenal Exclusion (GLYDE Study): Effects of GLY-200 in healthy humans and people with uncomplicated type 2 diabetes.

Phase 2

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

• Registration Number: ACTRN12624000097549
• Lead Sponsor: The University of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-02
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Healthy Volunteers
•Healthy males and females aged between 40 to 79 years
•Body mass index (BMI) between 19 to 32 kg/m2
•HbA1c less than 5.7%
•Fasting blood glucose less than 5.6 mmol/L

T2D patients
•Type 2 diabetes (T2D, World Health Organisation criteria)
•Males and females aged from 40 to 79 years
•BMI from 20 to 40 kg/m2 (i.e. a higher range than in the healthy participants to allow for the greater tendency for overweight/obesity in people with T2D)
•HbA1c less than 8.5% on stable (over 3 months) treatment with diet and/or metformin alone

Exclusion Criteria

•Use of any medication that may influence gastrointestinal motor function, body weight or appetite (opiates, anticholinergics, levodopa, clonidine, nitrates, phosphodiesterase type 5 inhibitors, sumatriptan, GLP-1 receptor agonists, metoclopramide, domperidone, prucalopride, or erythromycin)
•Use of medications that raise gastric pH, including proton pump inhibitors and H2 receptor antagonists
•Evidence of drug abuse, or consumption of more than 20 g alcohol, or 10 cigarettes, daily
•History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms (once weekly or more, or any history of swallowing difficulties, on the Digestive Health and Wellbeing Survey Short Form) or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
•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 or respiratory disease
•Haemoglobin below the lower limit of the normal range (ie. less than 135 g/L for men and 115 g/L for women), and ferritin below the lower limit of normal (ie. less than 30 mg/mL)
•Impaired renal or liver function (as assessed by calculated estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73m2 or abnormal liver function tests (more than 1.5 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
•Exposure to ionising radiation for research purposes that exceeds 3.5 mSv within the previous 12 months
•Inability to give informed consent
•Female participants who are pregnant or planning for pregnancy, or are lactating

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in blood glucose (area under the curve (AUC) from 0 to 360 min) between study days after GLY-200 and placebo treatment.[Blood glucose concentration will be measured by a YSI analyser. t = -10, 15, 30, 60, 90, 120, 180, 240, 300, and 360 min on the last day of the treatment period 1 and period 2.<br>t = -60 is when capsules containing the study drug or placebo were given and t = -5 is when the mashed potato meal is given.]