Endogenous GLP-1 Secretion on Islet Function in People With and Without Type 2 Diabetes
Condition: Healthy; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Saline; Exendin-9,39; Saline + Intralipid/Heparin; Exendin-9,39 + Intralipid/Heparin
Intervention description: Saline infused during the study; Exendin-9,39 infused during the study; Saline infused during acute insulin resistance; Exendin-9,39 infused during acute insulin resistance
Intervention MeSH terms: Heparin; Calcium heparin; Soybean oil, phospholipid emulsion
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      GLP-1 is a hormone made by the body that promotes the production of insulin in response to
      GLP-1 is produced within the islets expressing prohormone convertase 1/3eating. However,
      there is increasing evidence that this hormone might help support the body's ability to
      produce insulin when diabetes develops. The purpose of this study is to determine the effect
      of endogenous GLP-1 secretion on insulin secretion in people with and without type 2
      diabetes.
    

Eligibility criteria:

        Inclusion criteria - non-diabetic subjects:

          -  Weight-stable, non-diabetic subjects

        Exclusion Criteria - non-diabetic subjects:

          -  Age < 25 or > 65 years (to avoid studying subjects who could have latent type 1
             diabetes, or the effects of age extremes in subjects with normal or impaired fasting
             glucose).

          -  HbA1c ≥ 6.5%

          -  Use of glucose-lowering agents.

          -  For female subjects: positive pregnancy test at the time of enrollment or study

          -  History of prior upper abdominal surgery such as adjustable gastric banding,
             pyloroplasty and vagotomy.

          -  Active systemic illness or malignancy.

          -  Symptomatic macrovascular or microvascular disease.

        Inclusion criteria - diabetic subjects:

          -  Weight-stable, diabetic subjects treated with diet and lifestyle alone or with
             metformin monotherapy

        Exclusion Criteria - diabetic subjects:

          -  Age < 25 or > 65 years (to avoid studying subjects who could have latent type 1
             diabetes, or the effects of age extremes in subjects with normal or impaired fasting
             glucose).

          -  Use of any glucose-lowering agent other than metformin.

          -  2 or more fasting glucose values > 250mg/dl on medication or after medication
             withdrawal.

          -  Unwillingness or inability to withdraw medication for three weeks prior to, and for
             the duration of the study.

          -  For female subjects: positive pregnancy test at the time of enrollment or study

          -  History of prior upper abdominal surgery such as adjustable gastric banding,
             pyloroplasty and vagotomy.

          -  Active systemic illness or malignancy.

          -  Symptomatic macrovascular or microvascular disease.