The Effects of Experimental Elevation of Plasma Glucose and Lipid on Pancreatic Beta-cell Function in Humans
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Insulin Secretion
Study Overview
Brief Summary
Elevations of blood glucose and lipid are thought to be deleterious to the insulin secretory function of the pancreas. This is known as glucolipotoxicity. However, few studies have examined this in detail. This investigation will examine pancreatic insulin secretory function in physiological models of glucolipotoxicity such as obese and type 2 diabetic individuals. Furthermore, healthy subjects will undergo 24 hour infusion of glucose or Intralipid to induce experimental models of glucolipotoxicity. Insulin secretion in response to intravenous infusions of glucose, GLP-1, GIP, and arginine and in response to meal ingestion, will be examined. the investigators hypothesize that experimental glucolipotoxicity will impairs pancreatic insulin secretory function to levels akin to that seen in type 2 diabetics.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •normal glucose tolerance based on screening OGTT or
- •diagnosed type 2 diabetic (confirmed with OGTT)
Exclusion Criteria
- •insulin dependent diabetes
- •age <18 or >65 years
- •BMI <20 or > 35 kg/m2
- •evidence of hematological, pulmonary, hepatic, renal, or cardiovascular disease
- •actively undergoing weight-loss (>2kg change in last 6 months)
- •bariatric surgery (gastric by-pass or banding)
- •pregnancy
Outcomes
Primary Outcomes
Insulin Secretion
Time Frame: 24 hours
Insulin secretion will be assessed in response to intravenous infusions of glucose, GLP-1, GIP, and arginine, and in response to meal ingestion.
Secondary Outcomes
- Plasma Cytokines (IL-6, TNF, IL-1beta, IL-1ra)(24 hours)
- Insulin Sensitivity(24 hours)
Investigators
Thomas Solomon
Group Leader
Rigshospitalet, Denmark