Trials / Withdrawn
WithdrawnNCT03520153
Characterization of Diabetes Mellitus in Fibrous Dysplasia/McCune-Albright Syndrome
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Yale University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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).
Detailed 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Hyperinsulinemic Euglycemic Clamp and 2H20 | Test is used to assess insulin effects on hepatic glucose production. |
| PROCEDURE | 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. |
Timeline
- Start date
- 2018-08-07
- Primary completion
- 2021-08-01
- Completion
- 2021-08-01
- First posted
- 2018-05-09
- Last updated
- 2019-09-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03520153. Inclusion in this directory is not an endorsement.