Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560060
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Do People With Complications of Type 1 Diabetes Mellitus Have a Different Microbiome MARVEL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Is the Gut Microbiome Associated With Residual Β-Cell Function and DeVElopment of Complications in Individuals With Longstanding Type 1 Diabetes Mellitus MARVEL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MARVEL
Brief Summary:
This study looks at whether people with type 1 diabetes have different gut bacteria We also want to see if this is linked to keeping insulin production up and preventing complications like heart disease and nerve damage The aim is to find ways to keep more of the functions working avoid low blood sugar and reduce diabetes complications
Detailed Description:
Rationale It has become apparent that most individuals with type 1 diabetes mellitus T1D have some remaining β-cell function Individuals with T1D and a preserved β-cell function have a lower risk of hypoglycemia and diabetic complications The factors regulating residual β-cell function are unknown A likely mechanism leading to β-cell preservation is regulation of immunological tone by the gut microbiome Recently we published in a small pilot cohort GUTDM1 METC 2020_105 that residual β-cell function is linked to better glycemic control time in range and linked to specific gut microbiota composition Since this cohort was too small to also show a link with presence of diabetic complications and recruit enough individuals with preserved β-cell function for confirmatory intervention trials to increase β-cell function we will now aim to recruit a larger follow-up cohort The aim of this cohort is to a investigate whether residual β-cell function is associated with gut microbiome composition and circulating immune cell counts in individuals with T1D and diabetic complications b identify 500 potential eligible individuals with preserved β-cell function for future intervention trials
Objective
1 To investigate whether T1D individuals with preserved β-cell function exhibit a distinct gut microbial and circulating immune cell signature leading to a reduced incidence of diabetes complications CVD nephropathy neuropathy and retinopathy
2 Identify individuals with preserved β-cell function for diagnostics as well as future intervention studies to increase β-cell function
Study design 10-year longitudinal observational multicenter cohort study
Study population 5000 individuals with type 1 diabetes 18 years of age visiting the outpatient clinic of Diabeter center Amsterdam and Diabeter Nederland
Main study parametersendpoints The primary endpoint is long-term residual β-cell function as assessed by baseline and stimulated 2-hour post meal urinary C-peptide levels at 36 and 10 years follow-up The secondary endpoint pertains presence and incidence of diabetes complications cardiovascular disease nephropathy neuropathy and retinopathy gut microbiota composition measured in feces with shotgun sequencing glucose time-in-range CGM-metrics and subsequent exogenous insulin dose Tertiary endpoints include the profiling of immune cell subsets assessment of autoreactive T lymphocytes and HLA typing by high resolution sequencing of circulating leukocytes IMMOCHIP in relation to untargeted plasma metabolomics Metabolon
Nature and extent of the burden and risks associated with participation benefit and group relatedness This study is considered a negligible-risk study The patient will complete several questionnaires keep track of a food diary and collect urine and feces prior to the baseline study visit At the study visit we will require a fasted plasma sample this will slightly increase the chances of a hypoglycemic episode largely mitigated because all participants carry a continues glucose monitor Additionally we will calculate BMI waist circumference liver stiffness and measure blood pressure The questionnaires inquire about the burden of diabetic complications socio-economic status and financial literacy abdominal complaints and hypoglycemic episodes and comorbidities associated with diabetes quality of life and psychological functioning We argue that the risk and discomfort associated with this study is similar to the yearly diabetes check-up and justified in light of the potentially profound insights and novel treatments to be gained by studying the impact of the gut microbiome on residual β-cell function in T1D
Objective
1 To investigate whether T1D individuals with preserved β-cell function exhibit a distinct gut microbial and circulating immune cell signature leading to a reduced incidence of diabetes complications CVD nephropathy neuropathy and retinopathy
2 Identify individuals with preserved β-cell function for diagnostics as well as future intervention studies to increase β-cell function
Study design 10-year longitudinal observational multicenter cohort study
Study population 5000 individuals with type 1 diabetes 18 years of age visiting the outpatient clinic of Diabeter center Amsterdam and Diabeter Nederland
Main study parametersendpoints The primary endpoint is long-term residual β-cell function as assessed by baseline and stimulated 2-hour post meal urinary C-peptide levels at 36 and 10 years follow-up The secondary endpoint pertains presence and incidence of diabetes complications cardiovascular disease nephropathy neuropathy and retinopathy gut microbiota composition measured in feces with shotgun sequencing glucose time-in-range CGM-metrics and subsequent exogenous insulin dose Tertiary endpoints include the profiling of immune cell subsets assessment of autoreactive T lymphocytes and HLA typing by high resolution sequencing of circulating leukocytes IMMOCHIP in relation to untargeted plasma metabolomics Metabolon
Nature and extent of the burden and risks associated with participation benefit and group relatedness This study is considered a negligible-risk study The patient will complete several questionnaires keep track of a food diary and collect urine and feces prior to the baseline study visit At the study visit we will require a fasted plasma sample this will slightly increase the chances of a hypoglycemic episode largely mitigated because all participants carry a continues glucose monitor Additionally we will calculate BMI waist circumference liver stiffness and measure blood pressure The questionnaires inquire about the burden of diabetic complications socio-economic status and financial literacy abdominal complaints and hypoglycemic episodes and comorbidities associated with diabetes quality of life and psychological functioning We argue that the risk and discomfort associated with this study is similar to the yearly diabetes check-up and justified in light of the potentially profound insights and novel treatments to be gained by studying the impact of the gut microbiome on residual β-cell function in T1D
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None