Diabetes Mellitus Clinical Trial
Official title:
Characterization of Diabetes Mellitus in Fibrous Dysplasia/McCune-Albright Syndrome
NCT number | NCT03520153 |
Other study ID # | 2000022658 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | August 7, 2018 |
Est. completion date | August 2021 |
Verified date | July 2019 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The investigators' objective is to understand the pathogenesis of diabetes mellitus in Fibrous dysplasia/McCune-Albright syndrome (FD/MAS) by: 1) establishing the contributions of insulin resistance versus impaired insulin secretion, 2) investigating presence of excess glucagon signaling by measuring gluconeogenesis and glycogenolysis, and 3) investigating a potential interaction between diabetes and intraductal papillary mucinous neoplasms (IPMNs).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 2021 |
Est. primary completion date | August 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Fibrous dysplasia/McCune-Albright syndrome (FD/MAS) group: - Must be diagnosed based on clinical grounds and/or mutation testing on bone and/or affected tissue Control group: - Must be at least 18 years old Exclusion Criteria: Fibrous dysplasia/McCune-Albright syndrome (FD/MAS) group: - Unwilling to fully cooperate with the evaluation - Unable to provide informed consent Control group: - History of diabetes, insulin resistance, pancreatic disease, pancreatic cysts or amylase/lipase abnormality - Use of any type of oral diabetes medications and/or insulin - Unable to provide informed consent |
Country | Name | City | State |
---|---|---|---|
United States | Yale New Haven Hospital | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Maturity-Onset Diabetes of Young (MODY) genetic testing | The test detects deletions in the HNF4A, GCK, HNF1A, HNF1B genes and mutations in the HNF4A, GCK, HNF1A, HNF1B and IPF1. Will be obtained at baseline before the start of oral glucose tolerance test only in those subjects with an existing diagnosis of diabetes mellitus. | Baseline | |
Primary | Glucose tolerance status | An oral glucose tolerance test will be performed to assess glucose tolerance status to determine if subjects have pre-IGT, IGT or diabetes | Baseline | |
Primary | Insulin sensitivity | This primary outcome will be obtained from the oral glucose tolerance test | Baseline | |
Primary | Insulin secretion | This primary outcome will be obtained from the hyperglycemic clamp | Baseline | |
Primary | Beta cell capacity | AIRmax stimulation test during the hyperglycemic clamp to ascertain the maximal acute insulin response (AIR) to arginine, which is a measure of functional beta cell capacity. | Baseline | |
Primary | Hepatic glucose fluxes (gluconeogenesis and glycogenolysis) | Measurements from the Hyperinsulinemic Euglycemic Clamp/ 2H20 Study will be used to assess insulin effects on hepatic glucose production and glycerol kinetics isotopes and the deuterium enrichment at carbons 2 and 5 (C2 and C5) of plasma glucose providing information on glucose fluxes | At least 2 weeks post baseline testing | |
Secondary | Islet cell antibodies (ICA), | Peripheral blood draw before the start of oral glucose tolerance test | Baseline | |
Secondary | Glutamic acid decarboxylase antibodies (GAD65) | Peripheral blood draw before the start of oral glucose tolerance test | Baseline | |
Secondary | Islet antigen-2 antibodies (IA-2A) | Peripheral blood draw before the start of oral glucose tolerance test | Baseline | |
Secondary | Zinc transporter 8 (ZnT8) | Peripheral blood draw before the start of oral glucose tolerance test | Baseline | |
Secondary | Fasting lipid panel | Peripheral blood draw before the start of oral glucose tolerance test | Baseline | |
Secondary | Fasting incretins | Peripheral blood draw before the start of oral glucose tolerance test | Baseline | |
Secondary | Prandial incretins | Peripheral blood draw at the end of the oral glucose tolerance test | Baseline | |
Secondary | Free fatty acids | Peripheral blood draw before the start of oral glucose tolerance test | Baseline | |
Secondary | Growth hormone | Peripheral blood draw before the start of oral glucose tolerance test | Baseline | |
Secondary | Insulin-like growth factor-1 (IGF-1) | Peripheral blood draw before the start of oral glucose tolerance test | Baseline | |
Secondary | Renal function (BUN and creatinine) | Peripheral blood draw before the start of oral glucose tolerance test | Baseline | |
Secondary | Hemoglobin A1c | Peripheral blood draw before the start of oral glucose tolerance test | Baseline | |
Secondary | Urinalysis | Will be obtained at baseline before the start of oral glucose tolerance test to look for albuminuria | Baseline | |
Secondary | Glycerol | Peripheral blood draw before the start of oral glucose tolerance test | Baseline | |
Secondary | Leptin | Peripheral blood draw before the start of oral glucose tolerance test | Baseline | |
Secondary | Adiponectin | Peripheral blood draw before the start of oral glucose tolerance test | Baseline | |
Secondary | Liver function tests (AST and ALT) | Peripheral blood draw before the start of oral glucose tolerance test | Baseline | |
Secondary | C-reactive protein (CRP) | Peripheral blood draw before the start of oral glucose tolerance test | Baseline | |
Secondary | Interleukin 6 (IL-6) | Peripheral blood draw before the start of oral glucose tolerance test | Baseline | |
Secondary | Tumor necrosis factor alpha (TNF-alpha) | Peripheral blood draw before the start of oral glucose tolerance test | Baseline |
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