Diabetes Mellitus Clinical Trial
Official title:
Effects of Lixisenatide on Gastric Emptying, Glycaemia and 'Postprandial' Blood Pressure in Type 2 Diabetes and Healthy Subjects.
The purpose of this study is to determine the effects of the drug lixisenatide on blood sugar levels, stomach emptying, blood pressure and heart rate, release of gut hormones and blood flow in the gut after a glucose drink in both healthy subjects and people with type 2 diabetes. If lixisenatide is shown to be effective, it would encourage ongoing evaluation of its potential use in the management of the falls in blood pressure following a meal in diabetic patients.
Lixisenatide is a drug that has been shown to reduce postprandial glycaemia in people with
type 2 diabetes and is now approved for use in Australia. Although slowing of gastric
emptying is likely to be the dominant mechanism by which lixisenatide reduces postprandial
glycaemia after a meal, the effects of lixisenatide on gastric emptying have hitherto not
been quantified by the 'gold standard' technique of scintigraphy. The study would determine
and evaluate for the first time the magnitude of, and the relationship between lixisenatide
on glycaemia with those on gastric emptying with scintigraphy. This information will be of
fundamental significance to the effective use of lixisenatide in the management of people
with type 2 diabetes that suffer from postprandial hypotension.
Postprandial hypotension represents an important clinical disorder that occurs frequently in
the elderly and people with type 2 diabetes and for which current management is suboptimal.
While the mechanisms mediating postprandial hypotension are poorly understood, impaired
regulation of splanchnic blood flow, gastric distension, the rate of small intestinal
delivery and neural and hormonal mechanisms have been identified as possible
pathophysiological mechanisms. Meal ingestion is associated with splanchnic blood pooling
and a consequent reduction in venous return of blood to the heart. In healthy young and
older individuals, with intact baroreflex mechanisms, these changes induce a rise in heart
rate, stoke volume and cardiac output leading to a compensatory rise in blood pressure.
However, patients with postprandial hypotension, these responses are inadequate to maintain
blood pressure. The magnitude of the fall in blood pressure is greater when gastric emptying
is more rapid and that slowing gastric emptying can markedly attenuate the postprandial fall
in blood pressure in both healthy older subjects and type 2 patients.
There is currently no information about the effect of lixisenatide on postprandial blood
pressure and splanchnic blood flow in patients with type 2 diabetes.
The purpose of this study would determine whether lixisenatide reduces the postprandial fall
in blood pressure and related effects of gastric emptying to those on blood pressure, heart
rate and splanchnic blood flow.
The use of lixisenatide on appetite and energy intake and how these relate to effects of
gastric emptying is lacking.
It is hypothesized that lixisenatide will slow gastric emptying of oral glucose; attenuate
both fasting and the postprandial rise in blood glucose; attenuate the magnitude of the fall
in blood pressure, rise in heart rate and increase in SMA flow and reduce hunger, increase
fullness and decrease energy intake at a buffet meal with greater effects in patients with
type 2 diabetes that healthy subjects.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03743779 -
Mastering Diabetes Pilot Study
|
||
| Completed |
NCT03786978 -
Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus
|
N/A | |
| Completed |
NCT01804803 -
DIgital Assisted MONitoring for DiabeteS - I
|
N/A | |
| Completed |
NCT05039970 -
A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program
|
N/A | |
| Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
| Completed |
NCT04068272 -
Safety of Bosentan in Type II Diabetic Patients
|
Phase 1 | |
| Completed |
NCT03243383 -
Readmission Prevention Pilot Trial in Diabetes Patients
|
N/A | |
| Completed |
NCT03730480 -
User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)
|
N/A | |
| Recruiting |
NCT02690467 -
Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.
|
N/A | |
| Completed |
NCT02229383 -
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
|
Phase 3 | |
| Completed |
NCT06181721 -
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes
|
N/A | |
| Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
| Recruiting |
NCT04489043 -
Exercise, Prediabetes and Diabetes After Renal Transplantation.
|
N/A | |
| Withdrawn |
NCT03319784 -
Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
|
Phase 4 | |
| Completed |
NCT03542084 -
Endocrinology Auto-Triggered e-Consults
|
N/A | |
| Completed |
NCT02229396 -
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
|
Phase 3 | |
| Recruiting |
NCT05544266 -
Rare and Atypical Diabetes Network
|
||
| Completed |
NCT01892319 -
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
|
||
| Completed |
NCT05031000 -
Blood Glucose Monitoring Systems: Discounter Versus Brand
|
N/A | |
| Recruiting |
NCT04039763 -
RT-CGM in Young Adults at Risk of DKA
|
N/A |