Completed

Liraglutide's Role in Preventing Type 2 Diabetes in Women with Prior Gestational Diabetes Mellitus

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Study Aim

This study aims to evaluate if Liraglutide can prevent the development of Type 2 Diabetes in women who have previously had Gestational Diabetes Mellitus, by observing changes in glucose tolerance through a 4-hour oral glucose tolerance test.

What is being tested

Liraglutide

+ Placebo

Drug
Who is being recruted

Urogenital Diseases+7

+ Diabetes Mellitus

+ Endocrine System Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 4
Interventional
Study Start: July 2012
See protocol details

Summary

Principal SponsorTina Vilsboll
Last updated: November 4, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01795248
Principal SponsorTina Vilsboll
Last updated: November 4, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

105 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesDiabetes MellitusEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsMetabolic DiseasesNutritional and Metabolic DiseasesPregnancy ComplicationsGlucose Metabolism DisordersDiabetes Mellitus, Type 2Diabetes, Gestational

Criteria

Inclusion Criteria for women with previous GDM: Informed oral and written consent Previous diagnosis of GDM according to current Danish guidelines (mainly PG concentrationa t 120 min after 75 g OGTT ≥ 9.0 mM) during pregnancy within the last 5 years Age >18 years 25 kg/m2 < BMI < 45 kg/m2 NGT, IFG and or IGT Safe contraception and negative pregnancy test Exclusion Criteria for women with previous GDM: Patients with diabetes HbA1c ≥6.5% Patients with previous pancreatitis or previous neoplasia Pregnant or breast feeding women Anaemia (haemoglobin <7 mM) Women planning to become pregnant within the next 5 years Women using other contraception than intrauterine device (IUD) or oral contraceptives. Women who do not use safe contraception will be offered application of an IUD. Women treated with statins, corticosteroids or other hormone therapy (except estrogens and gestagens) Ongoing abuse of alcohol or narcotics Impaired hepatic function (liver transaminases >3 times upper normal limit) Impaired renal function (se-creatinine >120 μM and/or albuminuria) Uncontrolled hypertension (systolic blood pressure >180 mmHg, diastolic blood pressure >100 mmHg) Any condition that the investigator feels would interfere with trial participation Receiving any investigational drug within the last 3 months Inclusion criteria for women without previous GDM: Informed oral and written consent Age >18 years 25 kg/m2 < BMI < 45 kg/m2 NGT Safe contraception and negative pregnancy test Pregnancy within the last ten years without GDM Exclusion Criteria for women without previous GDM : Pregnant or breast feeding women Anaemia (haemoglobin <7 mM) Inclusion Criteria for women without previous GDM and without NAFLD: Informed oral and written consent Age >18 years 25 kg/m2 < BMI < 45 kg/m2 NGT At least one pregnancy witin the last ten years without GDM Exclusion Criteria for women without previous GDM and without NAFLD: Pregnant or breast feeding women Anaemia (haemoglobin <7 mM) Steatosis as assessed by ultrasound scanning Recieving any investigational drug within the last 3 months Any condition that the investigator feels would interfere with the trial participation Inclusion Criteria for women with biopsi-verified NAFLD: Informed oral and written consent Women with known NAFLD or NASH Age >18 years 25 kg/m2 < BMI < 45 kg/m2 NGT At least one prior pregnancy Exclusion Criteria for women with biopsi-verified NAFLD: women with established cirrhosis Pregnant or breast feedning women Anaemia (haemoglobin <7 mM) Women treated with statins, corticosteroids or other hormone therapy ( except oestrogens and gestagens) Ongoing abuse of alcohol or narcotics Impaired renal function (se-creatinine > 120 μM and/or albuminuria) Uncontrolled hypertension (systolic blood pressure > 180 mmHg, diastolic blood presure > 100 mmHg) Any condition that the investigator feels would interfere with trial participation

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
1.8 mg liraglutide, subcutaneous, once-daily for five years

Group II

Placebo
Placebo, subcutaneous, once-daily for one year

Group III

No Intervention
Control without previous GDM.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen

Hellerup, DenmarkOpen Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen in Google Maps
CompletedOne Study Center