Liraglutide Actions on the Liver: Effects on Glucose Phosphorylation
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|ClinicalTrials.gov Identifier: NCT02198209|
Recruitment Status : Withdrawn (Investigator decided not to move forward with study prior to study start date)
First Posted : July 23, 2014
Last Update Posted : September 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: Liraglutide||Phase 4|
It is known that liraglutide impacts favorably glucose homeostasis in type 2 diabetic patients, but not the exact mechanism of this effect. In particular, liraglutide's acute and chronic effects on the liver are not well understood. The aim of our study is to determine whether liraglutide acutely and/or chronically changes hepatic GCK activity in vivo in type 2 diabetic patients, and to quantify this effect. We hypothesize that liraglutide increases GCK activity and that this results in increased hepatic glucose uptake, contributing to a lowering of glycemia.
Our specific aims are:
- to measure liraglutide's acute effect on GCK activity changes in vivo in type 2 diabetic patients;
- to assess whether chronic treatment with liraglutide determines a change in liver GCK activity in type 2 diabetic patients, as assessed during an IVGTT.
We expect that liraglutide acutely and/or chronically increases GCK activity, thus contributing to higher liver glucose uptake and lower glycemia.
- GCK activity (acute effect) during IVGTTs with and without liraglutide administration. GCK activity will be calculated based on lactate and glucose measurements during the IVGTT
- GCK activity during IVGTTs before and after 6 weeks of liraglutide treatment (IVGTT3).
- SI-IVGTT (insulin sensitivity during an intravenous glucose tolerance test) as quantified by the MINMOD analysis of the IVGTT
- Acute insulin response to glucose (AIRg) and the disposition index (DI-MINMOD), the ability of beta cell to compensate for changes in insulin sensitivity.
This is a study designed to investigate the effect of liraglutide in type 2 diabetes therefore subjects are selected from type 2 diabetes population of the Los Angeles basin area. The study population is represented by type 2 diabetics (age 18-65 y old, T2DM diagnosed by current American Diabetes Association diagnostic criteria ( HbA1c ≥ 6.5 % or fasting plasma glucose ≥ 126 mg/dl or 2h plasma glucose ≥ 200 mg/dL during an OGTT or in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis a random plasma glucose ≥ 200 mg/dl).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Liraglutide Actions on the Liver: Effects on Glucose Phosphorylation|
|Estimated Study Start Date :||December 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2020|
Other Name: Victoza
- Liver glucokinase activity (acute effect) [ Time Frame: 12 months ]We will measure liver glucokinase (GCK) activity 'in vivo' during IVGTTs with and without liraglutide administration
- Liver glucokinase activity (chronic effect) [ Time Frame: 12 months ]We will measure liver glucokinase (GCK) activity 'in vivo' during IVGTTs before and after 6 weeks of daily liraglutide administration
- insulin sensitivity [ Time Frame: 12 months ]We will measure SI-IVGTT (insulin sensitivity during an intravenous glucose tolerance test) as quantified by the MINMOD analysis of the IVGTT.
- Acute insulin response to glucose and the disposition index [ Time Frame: 12 months ]We will assess the acute insulin response to glucose (AIRg) and the disposition index (DI-MINMOD)(the ability of beta cell to compensate for changes in insulin sensitivity)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198209
|United States, California|
|Cedars Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Viorica Ionut, MD PhD||Cedars-Sinai Medical Center|