Obesity Clinical Trial
Official title:
Probiotics in Diabesity: A Pilot Study
Obesity and type 2 diabetes are a pandemic disease leading to a high morbidity and mortality.
Probiotic modulation of gut flora is a possible therapeutic mechanism.
The aim of this study is to investigate and compare thoroughly the effect of a multispecies
probiotic on glycaemic control, gut microbiota and gut permeability in patients with
metabolic syndrome and diabetes.
Obesity and diabetes probably represent the most challenging threat to public health in the
21st century. The World Health Organization (WHO) predicts that by 2015 approximately 2.3
billion adults will be overweight (BMI 25-29.9 kg/m²), and more than 700 million will be
obese (BMI 30 kg/m² or more). In addition, currently 285 million people worldwide suffer from
type 2 diabetes (T2DM), and this number is predicted to increase to 439 million by 2030. T2DM
raises the risk for cardiovascular morbidity and mortality, as well as eye problems, nerve
damage and kidney diseases. Previous studies demonstrated that the impact of diabetes on
everyday life and the likelihood of costly and disabling complications can be reduced by more
intensive management of glucose, blood pressure and cholesterol. Weight reduction is the most
desired but also most difficult to achieve treatment option in obesity, that is able to
prevent secondary complications of obesity and T2DM.
Since weight reduction by diet and increased physical activity alone is difficult to achieve
in morbidly obese subjects, other, more aggressive approaches, such as bariatric surgery have
been invented.
Recent preclinical and clinical studies have indicated an important influence of the
intestinal microbiome (gut metagenome) on obesity and associated metabolic disorders
(metabolic syndrome, type 2 diabetes, metabolic liver diseases, cardiovascular diseases). For
instance, the cecum microbiota of rodents was found to be significantly different in obese
than in lean mice. This finding of altered gut microbiota was then confirmed and extended to
humans. Additionally, these investigations in humans demonstrated that as obese people lose
weight, the composition of microflora shifted, and more closely resembled that of the lean
individuals. This suggests that the microflora might be involved in the pathogenesis of
obesity, insulin resistance and T2DM by having an impact on gut permeability and chronic
inflammation. Probiotic, prebiotic or synbiotic interventions have been shown to be effective
in modulating gut permeability and gut microbiota in animals and thereby modulating chronic
inflammation and metabolic disorders in animal models. In humans this has not been shown
unequivocally so far.
However, it is yet unknown, who will benefit from which intervention and why individuals
respond differently to these interventions.
The aim of this study is to investigate and compare thoroughly the effect of a multispecies
probiotic on glycaemic control, gut microbiota and gut permeability in patients with
metabolic syndrome and diabetes. The investigators aim to access changes in insulin
sensitivity, islet function and the secretion of gut hormones. In addition, the investigators
will investigate changes in gut microbiota and gut permeability to understand the underlying
mechanism. After investigating the mechanism the overarching aim is to identify biomarkers,
which would allow better prediction of treatment success. In future this would allow
tailoring obesity and diabetes treatment in order to give every patient the optimal treatment
at lowest costs.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |