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

• Register: ISRCTN
• Last refreshed on: 3 July 2017
• Main ID: ISRCTN76189107
• Date of registration: 22/12/2016
• Prospective Registration: Yes
• Primary sponsor: Clinical Research Centre - University College Dublin
• Public title: 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
• Scientific title: An open-label randomized trial of an intensive lifestyle package supported with Liraglutide treatment in obese, non-pregnant women with previous history of Gestational Diabetes Mellitus
• Date of first enrolment: 01/04/2017
• Target sample size: 50
• Recruitment status: Recruiting
• URL: http://isrctn.com/ISRCTN76189107
• Study type: Interventional
• Study design: Single-centre open label randomised controlled trial (Prevention)

Countries of recruitment

Ireland

Contacts

• Name: Fionnuala McAuliffe

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

1. Gestational diabetes 2. Glucose intolerance 3. Obesity
Nutritional, Metabolic, Endocrine
1. Gestational diabetes 2. Glucose intolerance 3. Obesity

Intervention(s)

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 treatment package of an intensive lifestyle approach (including diet and physical activity advice) supported by a daily treatment of Liraglutide for a period of 6 months. The control group will have usual care.
At baseline and at 6 months an OGTT will be carried out and bloods analysed for metabolic parameters such as HOMA-IR, hsCRP, lipids and HbA1c.
A 3-day food diary and a lifestyle questionnaire will be given to participants, at baseline and at 6 months, to assess behaviour change, readiness and analyse nutritional quality of the diet.
At 6 months the intervention arm will complete an acceptability questionnaire to assess patient views of the intervention and a diary card to assess compliance with study medication.
At the end of the treatment/intervention period of 6 months the participant will have finished the study trial. Participants will be contacted if conception is achieved, to follow up in their potential development of gestational diabetes or impaired glucose tolerance.

Control arm as of 02/05/2017:
Control arm: Participants will receive intensive lifestyle alone. Participants will be followed up after 6 months.

Original control arm:
Control arm: Participants receive usual care, including general lifestyle advice. Participants will be followed up after 6 months.

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

EC 26.2016

Source(s) of Monetary Support

University College Dublin