Back to resultsGLP-1 and Hypoglycemia
Primary Purpose
Type 2 Diabetes Mellitus
Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Glucagon-Like Peptide- 1 (GLP-1) infusion
Placebo Comparator: Saline Infusion
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring hypoglycemia, GLP-1, Type 2 diabetes, endothelial function
Eligibility Criteria
Inclusion Criteria:
- 14 (7 males, 7 females) healthy controls age 30-60 yr.
- 14 (7 males, 7 females) people with type 2 DM age 30-60 yr.
- For type 2 DM: HbA1c 6-10.0%
- No significant diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc.)
- Body mass index >25kg • m-2
Exclusion Criteria:
-
Sites / Locations
- University of Maryland, Baltimore
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Glucagon-Like Peptide -1 (GLP-1) infusion
Saline Infusion
Arm Description
Infusion of GLP-1 during experimental period
Saline infusion during experimental period
Outcomes
Primary Outcome Measures
Change in Plasminogen Activation inhibitor-1 (PAi-1)
measurements of change in PAi-1 at baseline and during the end of the glucose clamp period (2 hours)
Change in Flow mediated dilation (FMD)
flow mediated dilation of the brachial artery will be measured for change from baseline and end of glucose clamp (~4 hours)
Secondary Outcome Measures
Full Information
NCT ID
NCT01858896
First Posted
May 13, 2013
Last Updated
February 10, 2023
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT01858896
Brief Title
GLP-1 and Hypoglycemia
Official Title
Hypoglycemia Associated Autonomic Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2013 (undefined)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Low blood sugar can negatively affect how blood vessels function, and this can lead to an increase in the risk for heart attacks, strokes and other problems related to the stiffening and blockage of blood vessels. The purpose of this study is to learn if and how glucagon-like peptide-1 (GLP-1; a naturally occurring hormone in the gut) changes the effects that low blood sugar levels have on blood vessels.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
hypoglycemia, GLP-1, Type 2 diabetes, endothelial function
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Glucagon-Like Peptide -1 (GLP-1) infusion
Arm Type
Active Comparator
Arm Description
Infusion of GLP-1 during experimental period
Arm Title
Saline Infusion
Arm Type
Placebo Comparator
Arm Description
Saline infusion during experimental period
Intervention Type
Drug
Intervention Name(s)
Glucagon-Like Peptide- 1 (GLP-1) infusion
Other Intervention Name(s)
GLP-1
Intervention Description
GLP-1 infusion during experimental period
Intervention Type
Other
Intervention Name(s)
Placebo Comparator: Saline Infusion
Other Intervention Name(s)
Saline infusion
Intervention Description
Saline infusion (placebo) during experimental period
Primary Outcome Measure Information:
Title
Change in Plasminogen Activation inhibitor-1 (PAi-1)
Description
measurements of change in PAi-1 at baseline and during the end of the glucose clamp period (2 hours)
Time Frame
change from baseline to end of clamp period
Title
Change in Flow mediated dilation (FMD)
Description
flow mediated dilation of the brachial artery will be measured for change from baseline and end of glucose clamp (~4 hours)
Time Frame
change from baseline and end of clamp
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
14 (7 males, 7 females) healthy controls age 30-60 yr.
14 (7 males, 7 females) people with type 2 DM age 30-60 yr.
For type 2 DM: HbA1c 6-10.0%
No significant diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc.)
Body mass index >25kg • m-2
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen N Davis, MBBS
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
GLP-1 and Hypoglycemia
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