Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen
Hellerup, 2900, Denmark
NCT Number: NCT01795248
It is well-known that women with previous gestational diabetes mellitus are in risk of developing type 2 diabetes later in life; approximately half of the women develop overt type 2 diabetes within the first 10 years after pregnancy. Knowing this, we want to examine the effect of the type 2 diabetes medicine, liraglutide (Victoza), in women with previous gestational diabetes with the aim of reducing the risk of developing type 2 diabetes.
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Notify Me18 year and older
Female
Interventional
Phase 4
Hellerup, 2900, Denmark
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for women with previous GDM:
Exclusion criteria
for women with previous GDM:
Inclusion criteria
for women without previous GDM:
Exclusion criteria
for women without previous GDM :
Inclusion criteria
for women without previous GDM and without NAFLD:
Exclusion criteria
for women without previous GDM and without NAFLD:
Inclusion criteria
for women with biopsi-verified NAFLD:
Exclusion criteria
for women with biopsi-verified NAFLD:
1.8 mg liraglutide
Other names: Victoza, NN2211
Liraglutide without the GLP-1 analogue
Time frame: from baseline to 52 wks, 53 wks, 260 wks, and 261 wks
Changes in glucose is measured by area under the curve for the plasma glucose excursion following a 4-hour 75 g oral glucose tolerance test (OGTT)
Time frame: from baseline to 52 wks, 53, wks, 260 wks, and 261 wks
Percentage of subjects in each treatment arm with normal glucose tolerance (NGT) at inclusion who develop impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) or type 2 diabetes; or with IFG or IGT who develop combined IFG/IGT; or with combined IFG/IGT who develop type 2 diabetes
Time frame: From baseline to 52 wks and 260 wks
Changes in glycated hemoglobin (HbA1c). From normoglycaemic to prediabetic or type 2 diabetic and from prediabetic to type 2 diabetic or normoglycaemic.
Time frame: from baseline to 52 and 260 wks
Changes in body mass index (BMI)(kg/m2), absolute body weight (kg), and waist:hip ratio
Time frame: from baseline to 52, 53, 260, and 261 wks
changes in area under the curve during OGTT and isoglycemic intravenous glucose infusion (IIGI), the homeostatic model assessment (HOMA) and pro-insulin ratio
Time frame: from baseline to 52, 53, 260, and 261 wks
assessed by HOMA-IR and Matsuda insulin sensitivity index
Time frame: baseline to 52, 53, 260, and 261 wks
measured as fasting plasma concentrations and plasma responses of GLP-1, GLP2, and GIP and plasma glucagon during OGTT
Time frame: baseline to 52, 53, 260, and 261 wks
insulin and c-peptide responses after OGTT vs. IIGI
Time frame: baseline to 52 and 260 wks
gamma-glutamyltranferase (GGT), intra-heptic fat, FGF-21, whole body and visceral fat mass/fat-free mass, circulating lipids, ultrasound scan and fibroscan
Time frame: baseline to 52 and 260 wks
pro-collagen 3, GGT, Intra-hepatic fat, whole body and visceral fat mass/fat-free mass, circulating lipids and cardiovascular biomarkers (highly sensitive c-reactive protein (hs-CRP), N-terminal prohormone of brain natriuretic peptide (NT-proBNP), tumor necrosis factor-alpha (TNF-alpha), adiponectin and plasminogen activator inhibior-1 (PAI-1))
Time frame: baseline to 52 and 260 wks
optional to the main protocol
Time frame: baseline to 52, 53, 260, and 261 wks
visual analogue scale (VAS)
Time frame: baseline to 52 and 260 wks
as assessed by validated questionnaires
Time frame: Baseline to 52 and 260 wks
Assessed by validated questionnaires (SF-36)
Time frame: baseline to 52 and 260 wks
By validated questionnaires
Time frame: baseline to 52 to 260 wks
Predicitve value of biomarkers for detection of microalbuminuria
Time frame: baseline to 52 wks
questionnaire and the end of the blinded trial
Time frame: baseline to 52 and 260 wks
Tina Vilsboll
Other
The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Gestational Diabetes Mellitus
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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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