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Clinical Trial Details

Trial ID: L3198
Source ID: NCT04239586
Associated Drug: Sulfonylurea
Title: Switching From Insulin to Sulfonylurea in Diabetes Associated With Variants in MODY Genes
Acronym: SUtoChildT1D
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Maturity-Onset Diabetes of the Young, Type 3|Maturity Onset Diabetes of the Young, Type 1|Childhood Diabetes Mellitus|Insulin-dependent Diabetes Mellitus
Interventions: DRUG: Sulfonylurea
Outcome Measures: Primary: Effect of sulfonylurea treatment on insulin requirement measured in units insulin per kg per day, Effect of sulfonylurea treatment on insulin requirement measured in units insulin per kg bodyweight per day, recorded at intervals of 3-6 months after exposure to sulfonylurea compared to before initiation of sulfonylurea, 5 years|Metabolic control of diabetes measured by HbA1c in mmol/mol, Metabolic control of diabetes measured by HbA1c in mmol/mol, recorded at intervals of 3-6 months after exposure to sulfonylurea compared to before initiation of sulfonylurea, 5 years | Secondary: Level of sulfonylurea dose in mg per kg per day, Level of sulfonylurea dose in mg per kg body weight per day, recorded at intervals of 3-6 months after exposure to sulfonylurea compared to before initiation of sulfonylurea, 5 years|Prevalence of side effects of sulfonylurea, Recording potential side effects of sulfonylurea, such as nausea, change in body weight, episodes of severe hypoglycemia, discolouration of teeth, diarrhoea, cardiovascular events, recorded at intervals of 3-6 months after exposure to sulfonylurea compared to before initiation of sulfonylurea, 5 years|Effect on endogenous insulin secretion assessed by intravenous glucose tolerance tests, Maximum increment of serum insulin in nmol/L and serum c-peptide in pmol/L at intravenous glucose tolerance tests, recorded at intervals of 6-12 months after exposure to sulfonylurea compared to before initiation of sulfonylurea, 5 years|Effect on secretion of incretin hormones, assessed by oral glucose tolerance tests, Maximum increment of serum insulin in nmol/L, serum c-peptide in pmol/L and incretins (GIP in pmol/L and GLP-1 in pmol/L) at oral glucose tolerance tests and in comparison with intravenous gluclose tolerance tests, recorded at intervals of 6-12 months after exposure to sulfonylurea compared to before initiation of sulfonylurea, 5 years
Sponsor/Collaborators: Sponsor: Haukeland University Hospital
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-04-18
Completion Date: 2022-04
Results First Posted:
Last Update Posted: 2020-01-27
Locations: Department of Pediatrics and Adolescents, Haukeland University Hospital, and Department of Clinical Science, Faculty of Medicine, University of Bergen, Bergen, NO-5021, Norway
URL: https://clinicaltrials.gov/show/NCT04239586