1. Gestational diabetes 2. Glucose intolerance 3. Obesity Nutritional, Metabolic, Endocrine 1. Gestational diabetes 2. Glucose intolerance 3. Obesity
Conditions
Interventions
Eligible participants are randomised to one of two groups in a ratio of 1:1 for usual care versus intervention using computer-generated allocation.
Intervention arm: The study intervention involves a
Sponsors
Clinical Research Centre - University College Dublin
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Severe obesity BMI= 35 kg/m2 without Type 2 Diabetes Mellitus and with previous gestational diabetes (with or without insulin) 2. Participants must be able and willing to give written informed consent and to comply with the requirements of this study protocol 3. Participant must be a female, aged 18 years or above at baseline 4. Planning a pregnancy within the next one to two years 5. Negative pregnancy test 6. Contraception during the study period Removed 02/05/2017: Post pregnancy Type 2 Diabetes Mellitus with BMI= 30 kg/m2 and HbA1C >42 mmol/mol
Exclusion criteria
Exclusion criteria: 1. Allergy/sensitivity to study medication 2. Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study period 3. Medical disorder requiring medication other than stable hypertension, hypothyroidism, polycystic ovarian syndrome 5. Ongoing abuse of alcohol or narcotics 6. Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC) 7. Personal history of non-familial medullary thyroid carcinoma 8. History of acute or chronic pancreatitis 9. Obesity induced by drug treatment 10. Use of approved weight lowering pharmacotherapy 11. Previous surgical treatment of obesity 12. History of major depressive disorder or suicide attempt 13. Uncontrolled hypertension 14. Subjects unable to provide written informed consent Added 30/05/2017: 15. Type 2 diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of eligible women who would agree to participate in the study. This will be calculated by the % of women who agree to study participation out of all those eligible women who were approached for study participation. 2. Acceptability of women of taking daily Liraglutide injections. This will be assessed by an acceptability questionnaire completed after 6 months of study participation 3. Proportion of women that complied with the study protocol and completed the study intervention. This will be assessed by adherence to study drug using a drug compliance diary, attendance at study visits, satisfactory collection of study endpoints | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fasting glucose levels are measured in fasting plasma samples at baseline and 6 months 2. Effect on glucose homeostasis after treatment, as measured by OGTT, HbA1c, HOMA-ir at baseline and 6 months 3. Effect on inflammatory markers, including C- reactive protein, as measured by blood samples at baseline and 6 months 4. Weight loss as assessed by weighing participants at baseline and 6 months 5. Gestational diabetes mellitus incidence and/or impaired glucose tolerance in a subsequent pregnancy as measured by a positive result in a future pregnancy for gestational diabetes using standard diagnostic criteria | — |
Countries
Ireland
Outcome results
None listed