GLP-1 and Hypoglycemia

University of Maryland Baltimore (UMB)

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Other: Placebo Comparator: Saline Infusion; Drug: Glucagon-Like Peptide- 1 (GLP-1) infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01858896

HP00055308

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

-

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups, including a placebo group

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

Active Comparator group

Description:

Infusion of GLP-1 during experimental period

Treatment:

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

Saline Infusion

Placebo Comparator group

Description:

Saline infusion during experimental period

Treatment:

Other: Placebo Comparator: Saline Infusion