GLP-1 and Hypoglycemia

NCT01858896 | Active Not Recruiting Early Phase 1 DMC

• 1 other identifier: HP00055308
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

hypoglycemia; GLP-1; Type 2 diabetes; endothelial function

Outcome Measures

Primary Outcomes (2)

• 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 from baseline to end of clamp period

• 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)

  change from baseline and end of clamp

Study Arms (2)

Glucagon-Like Peptide -1 (GLP-1) infusion

ACTIVE COMPARATOR

Infusion of GLP-1 during experimental period

Drug: Glucagon-Like Peptide- 1 (GLP-1) infusion

Saline Infusion

PLACEBO COMPARATOR

Saline infusion during experimental period

Other: Placebo Comparator: Saline Infusion

Interventions

Glucagon-Like Peptide- 1 (GLP-1) infusion DRUG

GLP-1 infusion during experimental period

Also known as: GLP-1

Glucagon-Like Peptide -1 (GLP-1) infusion

Placebo Comparator: Saline Infusion OTHER

Saline infusion (placebo) during experimental period

Also known as: Saline infusion

Saline Infusion

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• (7 males, 7 females) healthy controls age 30-60 yr.
• (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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypoglycemia

Interventions

Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Stephen N Davis, MBBS

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Medicine

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: May 21, 2013
• Study Start: July 1, 2013
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-09

Locations

US (1)