A pre-pregnancy study examining the effects of an intensive lifestyle package supported with Liraglutide treatment, a medication equivalent to a natural hormone produced in the stomach, in obese women with previous history of pregnancy diabetes

Recruiting

• Conditions: 1. Gestational diabetes2. Glucose intolerance3. Obesity; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN76189107
• Lead Sponsor: Clinical Research Centre - University College Dublin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-22
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 50

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>2. Acceptability of women of taking daily Liraglutide injections. This will be assessed by an acceptability questionnaire completed after 6 months of study participation<br>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 Outcome Measures

Name	Time	Method
1. Fasting glucose levels are measured in fasting plasma samples at baseline and 6 months<br>2. Effect on glucose homeostasis after treatment, as measured by OGTT, HbA1c, HOMA-ir at baseline and 6 months<br>3. Effect on inflammatory markers, including C- reactive protein, as measured by blood samples at baseline and 6 months<br>4. Weight loss as assessed by weighing participants at baseline and 6 months<br>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