Agiocur Pregranules
Drug6g before breakfast and 12g after dinner for first 28 days, and no medication for next 28 days for washout
Other names: Agio gran.
NCT Number: NCT03552991
The purpose of this study is to determine the effect of a commercial dietary fiber supplement on patients with type 2 diabetes mellitus, in the way of glucose control, insulin action in the body, and the gut microbiota (bacteria) abundance.
Looking for future studies?
Notify Me50 year and older
All sexes
Interventional
Phase 4
Fiber supplements such as psyllium are known to be beneficial to glycemic control in patients with type 2 diabetes mellitus (T2DM). Gut microbiota has a role in regulating host energy metabolism and systemic inflammation by several pathways such as short-chain fatty acid production, fasting-induced adipose factor expression, endocannabinoid system, and gut epithelial permeability. As dietary components can influence the composition of the microbiota, we hypothesized that fiber supplements could modify gut microbiota and consequently affect glycemic control and inflammatory condition in patients with T2DM.
The primary outcome was to assess the effect of fiber on glucose control (by comparing fasting glucose and glycoalbumin), insulin secretion and sensitivity. Secondary outcomes were the changes abundance of microbiota, incretins, and lipopolysaccharide (LPS).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(all of the followings):
Exclusion criteria
(at least one of the followings):
6g before breakfast and 12g after dinner for first 28 days, and no medication for next 28 days for washout
Other names: Agio gran.
Time frame: the 4th week of study
By comparing the level of 4th week, compared to baseline
Time frame: the 4th week of study
By comparing the level of 4th week, compared to baseline
Time frame: the 4th week of study
By comparing the level of 4th week, compared to baseline
Time frame: the 4th week of study
By comparing the level of 4th week, compared to baseline. QUICKI is derived from fasting blood glucose and insulin level, reflecting insulin sensitivity.
Time frame: the 4th week of study
By comparing the level of 4th week, compared to baseline
Time frame: the 4th week of study
By comparing the level of 4th week, compared to baseline
Time frame: the 4th week of study
By comparing the level of 4th week, compared to baseline
Time frame: the 4th week of study
By comparing the level of 4th week, compared to baseline
Time frame: the 4th week of study
By comparing the level of 4th week, compared to baseline
Samsung Medical Center
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05370781
Diabetes Mellitus, Diabetes Mellitus, Type 2
Ann Arbor, Michigan, United States
View Trial DetailsNCT06066528
Body Weight, Diabetes Mellitus
Anniston, Alabama, United States
View Trial DetailsNCT05984238
Diabetes Mellitus, Diabetes Mellitus, Type 2
Amsterdam, North Holland, Netherlands
View Trial DetailsNCT06080425
Diabetes Mellitus, Diabetes Mellitus, Type 2
Galveston, Texas, United States
View Trial Details