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OpenTrials
Completed

NCT Number: NCT01668485

Mechanisms of Glucose Counterregulation in Pancreatic Islet Transplantation

Pancreatic islet transplantation improves glucose counterregulation and stabilizes glycemic control in patients with type 1 diabetes mellitus prone to severe hypoglycemia even if insulin independence is not achieved. However, the extent and underlying metabolic pathways of this improvement are unknown. Investigators therefore compare systemic glucose turnover including lactate gluconeogenesis and muscle glucose utilization, between insulin-requiring islet transplant recipients, matched type 1 diabetic subjects who did not receive islet transplantation, and matched healthy non-diabetic subjects.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Justus Liebig University

Giessen, Hessia, 35392, Germany

About this study

Subjects (n=12 each group) undergo a hypoglycemic and a euglycemic hyperinsulinemic clamp in a randomized fashion. Systemic and skeletal muscle glucose and lactate kinetics are assessed using a combination of isotopic and forearm balance techniques.

Who can participate

Healthy volunteers accepted: Yes

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

T1DM/ITX+

Inclusion criteria

  • Type 1 Diabetes
  • Pancreatic islet transplantation

Exclusion criteria

  • Type 2 Diabetes

Treatment and study plan

Hypoglycemic and euglycemic glucose clamp

Procedure

Each study participant will be subjected to a continuous infusion of insulin at a rate of 0.8 mU·kg-1·min-1 to induce hypoglycemia (blood glucose 2.8-3 mmol/l) for 30 minutes. At least two weeks later an identical insulin infusion will be administered and euglycemia (blood glucose 5 mmol/l) will be targeted. The order of these interventions will be subject to randomization.

Primary outcomes

  1. Whole body glucose counterregulation

    Time frame: 6-8 weeks

    Whole body glucose counterregulation is the difference in glucose infusion rates required to maintain the glycemic goal between the hypoglycemic and euglycemic clamp. Clamps were performed at two time points at least two weeks apart. Participants will be followed for the duration of 6-8 weeks to perform the hypoglycemic and euglycemic clamp tests.

Secondary outcomes

  1. Systemic glucose release

    Time frame: 6-8 weeks

    Systemic glucose release is the amount of glucose released primarily from the liver into the blood compartment during a given time. The unit of measure is μmol/kg/min.

    Participants will be followed for the duration of 6-8 weeks to perform the hypoglycemic and euglycemic clamp tests that will yield this parameter.

  2. Skeletal muscle glucose disposal

    Time frame: 6-8 weeks

    Participants will be followed for the duration of 6-8 weeks to perform the euglycemic and hypoglycemic clamp tests. The unit of measure of this parameters is μmol/kg/min.

  3. Gluconeogenesis from lactate

    Time frame: 6-8 weeks

    This parameter is determined by labelled lactate infused into the proband. The rate of the de novo synthesis of glucose (gluconeogenesis) is determined by the degree of incorporation of the lactate label into glucose molecules. The unit of measure of this parameter is μmol/kg/min.

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Registry information

Official study title

Metabolic Studies in Type 1 Diabetic Patients After Allogenic Intraportal Islet Transplantation.

Important dates

Study start
2001
Primary completion
2010
Study completion
2011
First posted
Aug 20, 2012
Registry last updated
Aug 21, 2012

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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