Characterization of Diabetes Mellitus in Fibrous Dysplasia/McCune-Albright Syndrome

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Yale University

Status

Withdrawn

Conditions

McCune-Albright Syndrome
Diabetes Mellitus
Intraductal Papillary Mucinous Neoplasm
Fibrous Dysplasia

Treatments

Procedure: Hyperglycemic Clamp
Procedure: Hyperinsulinemic Euglycemic Clamp and 2H20
Diagnostic Test: Oral Glucose Tolerance Test

Study type

Observational

Funder types

Other

Identifiers

NCT03520153
2000022658

Details and patient eligibility

About

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).

Full 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: Establish the etiology of diabetes in FD/MAS Increase understanding of the role of IPMNs in pathogenesis of diabetes Provide critical insights into the pathogenesis of diabetes in FD/MAS

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

0 participants in 5 patient groups

FD/MAS with diabetes mellitus
Description:
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.
Treatment:
Diagnostic Test: Oral Glucose Tolerance Test
Procedure: Hyperinsulinemic Euglycemic Clamp and 2H20
Procedure: Hyperglycemic Clamp
FD/MAS without diabetes mellitus
Description:
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.
Treatment:
Diagnostic Test: Oral Glucose Tolerance Test
Procedure: Hyperinsulinemic Euglycemic Clamp and 2H20
Procedure: Hyperglycemic Clamp
FD/MAS without diabetes and without IPMN
Description:
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.
Treatment:
Diagnostic Test: Oral Glucose Tolerance Test
Procedure: Hyperinsulinemic Euglycemic Clamp and 2H20
Procedure: Hyperglycemic Clamp
FD/MAS without diabetes and with IPMN
Description:
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.
Treatment:
Diagnostic Test: Oral Glucose Tolerance Test
Procedure: Hyperinsulinemic Euglycemic Clamp and 2H20
Procedure: Hyperglycemic Clamp
Healthy Controls
Description:
Participants will receive the following interventions: Hyperinsulinemic Euglycemic Clamp and 2H20; Hyperglycemic Clamp; and Oral Glucose Tolerance Test.
Treatment:
Diagnostic Test: Oral Glucose Tolerance Test
Procedure: Hyperinsulinemic Euglycemic Clamp and 2H20
Procedure: Hyperglycemic Clamp

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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