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GLP-1 Agonist

GLP-1 for Low Blood Sugar

Phase < 1
Waitlist Available
Led By Stephen N Davis, MBBS
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
14 (7 males, 7 females) healthy controls age 30-60 yr.
No significant diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline and end of clamp

Summary

This trial will help researchers learn if a hormone can help mitigate the effects of low blood sugar on blood vessels, which could help reduce the risk for heart attacks and strokes.

Who is the study for?
This trial is for adults aged 30-60 with Type 2 Diabetes who have a body mass index over 25 and controlled blood sugar levels (HbA1c between 6-10%). It's also open to healthy individuals in the same age range. People with significant diabetic complications like retinopathy or neuropathy can't participate.
What is being tested?
The study is testing whether GLP-1, a hormone that occurs naturally in the gut, can reduce negative effects of low blood sugar on blood vessels. Participants will receive either GLP-1 infusion or saline as a placebo to compare outcomes.
What are the potential side effects?
Possible side effects from GLP-1 may include nausea, vomiting, diarrhea, abdominal pain, and potential allergic reactions. The saline placebo is unlikely to cause any direct side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a healthy individual aged 30-60.
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I do not have major complications from diabetes like eye or nerve damage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to end of clamp period
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to end of clamp period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Flow mediated dilation (FMD)
Change in Plasminogen Activation inhibitor-1 (PAi-1)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Glucagon-Like Peptide -1 (GLP-1) infusionActive Control1 Intervention
Infusion of GLP-1 during experimental period
Group II: Saline InfusionPlacebo Group1 Intervention
Saline infusion during experimental period

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
716 Previous Clinical Trials
381,086 Total Patients Enrolled
4 Trials studying Diabetes
23,990 Patients Enrolled for Diabetes
Stephen N Davis, MBBSPrincipal InvestigatorUniversity of Maryland, Baltimore
3 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Glucagon-Like Peptide-1 (GLP-1) (GLP-1 Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT01858896 — Phase < 1
Diabetes Research Study Groups: Glucagon-Like Peptide -1 (GLP-1) infusion, Saline Infusion
Diabetes Clinical Trial 2023: Glucagon-Like Peptide-1 (GLP-1) Highlights & Side Effects. Trial Name: NCT01858896 — Phase < 1
Glucagon-Like Peptide-1 (GLP-1) (GLP-1 Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01858896 — Phase < 1
~2 spots leftby Sep 2025
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