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NCT Number: NCT01375270

Glucolipotoxicity and Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre of Inflammation and Metabolism, Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • smoking

Treatment and study plan

Glucotoxicity

Procedure

Glucose will be infused intravenously for a 24 hour period to raise blood glucose concentrations 5 mM above basal.

Lipotoxicity

Procedure

Intralipid and heparin will be infused intravenously for a 24 hour period to raise blood free fatty acid concentrations to approximately 1 mM.

Primary outcomes

  1. 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

  1. Insulin Sensitivity

    Time frame: 24 hours

    Glucose kinetics will be assesed using [6,6-2H2]glucose. Rate of glucose disappearance during glucose infusion will be quantified per unit of plasma insulin to derive an estimate of insulin sensitivity.

  2. Plasma Cytokines (IL-6, TNF, IL-1beta, IL-1ra)

    Time frame: 24 hours

    Cytokines will be measured in plasma: IL-6, TNF-alpha, IL-1beta, IL-1 receptor antagonist, IL-8, IL-10, Interferon gamma. Peripheral blood mononuclear cells will be isolated.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

The Effects of Experimental Elevation of Plasma Glucose and Lipid on Pancreatic Beta-cell Function in Humans

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 17, 2011
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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