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Clinical Trial Details — Status: Withdrawn

Administrative data

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Status Withdrawn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

Study information

Verified date July 2019
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


Description:

Specific project aims include:

Aim 1: Determine insulin secretion and sensitivity in subjects with MAS-associated diabetes.

Aim 2: Measure gluconeogenesis and glycogenolysis in MAS-associated diabetes to investigate a potential role for excess glucagon signaling.

Aim 3: Determine if IPMN development is associated with impairment of insulin secretion prior to development of overt diabetes.

The authors expect that this study will:

1. Establish the etiology of diabetes in FD/MAS

2. Increase understanding of the role of IPMNs in pathogenesis of diabetes

3. Provide critical insights into the pathogenesis of diabetes in FD/MAS


Recruitment information / eligibility

Status Withdrawn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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Hyperinsulinemic Euglycemic Clamp and 2H20
Test is used to assess insulin effects on hepatic glucose production.
Hyperglycemic Clamp
Test of beta-cell function and insulin secretion. Involves increasing and maintaining blood glucose concentration with IV variable infusion of dextrose.
Diagnostic Test:
Oral Glucose Tolerance Test
The oral glucose tolerance test (OGTT) measures the body's ability to use a type of sugar, called glucose, that is the body's main source of energy. An OGTT can be used to diagnose prediabetes and diabetes.

Locations

Country Name City State
United States Yale New Haven Hospital New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

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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