Characterization of Diabetes Mellitus in Fibrous Dysplasia/McCune-Albright Syndrome
NCT ID: NCT03520153
Last Updated: 2019-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2018-08-07
2021-08-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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FD/MAS with diabetes mellitus
Fibrous Dysplasia/McCune-Albright Syndrome with diabetes mellitus.
Participants will receive the following interventions: Hyperinsulinemic Euglycemic Clamp and 2H20; Hyperglycemic Clamp; and Oral Glucose Tolerance Test.
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.
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.
FD/MAS without diabetes mellitus
Fibrous Dysplasia/McCune-Albright Syndrome without diabetes mellitus.
Participants will receive the following interventions: Hyperinsulinemic Euglycemic Clamp and 2H20; Hyperglycemic Clamp; and Oral Glucose Tolerance Test.
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.
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.
FD/MAS without diabetes and without IPMN
Fibrous Dysplasia/McCune-Albright Syndrome without diabetes mellitus and without intraductal papillary mucinous neoplasms.
Participants will receive the following interventions: Hyperinsulinemic Euglycemic Clamp and 2H20; Hyperglycemic Clamp; and Oral Glucose Tolerance Test.
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.
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.
FD/MAS without diabetes and with IPMN
Fibrous Dysplasia/McCune-Albright Syndrome without diabetes mellitus and with intraductal papillary mucinous neoplasms.
Participants will receive the following interventions: Hyperinsulinemic Euglycemic Clamp and 2H20; Hyperglycemic Clamp; and Oral Glucose Tolerance Test.
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.
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.
Healthy Controls
Participants will receive the following interventions: Hyperinsulinemic Euglycemic Clamp and 2H20; Hyperglycemic Clamp; and Oral Glucose Tolerance Test.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Yale University
OTHER
Responsible Party
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Principal Investigators
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Cemre Robinson, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale New Haven Hospital
New Haven, Connecticut, United States
Countries
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Other Identifiers
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2000022658
Identifier Type: -
Identifier Source: org_study_id
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