Preservation of insulin C-peptide in pregnant women with type 1 diabetes mellitus
| ISRCTN | ISRCTN15203878 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15203878 |
- Submission date
- 08/09/2016
- Registration date
- 15/09/2016
- Last edited
- 10/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Diabetes mellitus is a life-long condition where a person is unable to control their blood sugar levels. There are two main types of diabetes, type 1 (around 10% of cases) and type 2. In type 1 diabetes (T1DM) the immune system attacks specialised cells in the pancreas called beta cells (which are responsible for producing the hormone insulin). This means that the sufferer is unable to produce enough insulin to effectively control their blood sugar levels and so regularly inject insulin in order to keep their blood sugar levels in a healthy range. When insulin is made in the pancreas, another molecule called C-peptide is also produced. C-peptide does not affect blood sugar, but as it is found in equal amounts to insulin, testing C-peptide levels is a good way of finding out how much insulin there is in the body. Some studies have shown that fatty acids may be able to protect the pancreas, as well as helping promote normal growth of a baby during pregnancy. The aim of this study is to find out what the effects are when pregnant women with type 1 diabetes take fatty acid supplements on C-peptide and blood sugar control.
Who can participate?
Pregnant women aged between 18 and 40 with type 1 diabetes.
What does the study involve?
Women are randomly allocated to one of two groups. Those in the first group take supplements containing fatty acids (eicosapentanoic acid (EPA) and docosahexanoic acid (DHA)) at meal times from the start of the study (when they are 9 weeks pregnant) until they have their baby. Those in the second group take supplements containing a placebo (dummy pill) at meal times from the start of the study until delivery. At the start of the study and then when the women are 20 and 30 weeks pregnant, and at the time of delivery, blood samples are taken to assess how well they are managing their blood sugar levels.
What are the possible benefits and risks of participating?
Women who take the fatty acid supplements may benefit from lower levels of C-peptide, which could mean that they need to take less insulin. There is also evidence that taking fatty acids during pregnancy could aid the development of their baby’s brain. There are no notable risks involved with participating.
Where is the study run from?
Department of Obstetrics and Gynecology School of Medicine Zagreb (Croatia)
When is the study starting and how long is it expected to run for?
December 2013 to September 2019
Who is funding the study?
Ministry of Science, Education and Technology of the Republic of Croatia (Croatia)
Who is the main contact?
Prof. Josip Djelmis
josip.djelmis@zg.t-com.hr
Contact information
Scientific
Deparment of Obstetrics and Gynecology
School of Medicine
University of Zagreb
Petrova 13
Zagreb
1000
Croatia
 ORCID ID |
0000-0002-7332-5936 |
|---|---|
| Phone | +385 (0)1 4578330 |
| josip.djelmis@zg.t-com.hr |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The impact of EPA and DHA supplementation on C-peptide preservation in type 1 diabetic pregnant women |
| Study objectives | The aim of this study is to find the impact of eicosapentanoic acid (EPA) and docosahexanoic acid (DHA) supplementation on secretion of fasting C-peptide in pregnant women with type 1 diabetes. |
| Ethics approval(s) | Ethics Committee School of Medicine University of Zagreb, 12/12/2013, ref: 021-1/206 A-13 |
| Health condition(s) or problem(s) studied | Type 1 diabetes mellitus in pregnant women |
| Intervention | Participants are randomly allocated to one of two groups: Intervention group: Participants take capsules containing 60mg EPA (eicosapentanoic) and 308 mg DHA (docosahexanoic acid) twice a day at mealtimes during pregnancy, from baseline (9th week of gestation) until delivery. Control group: Participants take capsules containing a placebo twice a day at mealtimes during pregnancy, from baseline (9th week of gestation) until delivery. Throughout the study, participants attend standard visits at Clinics at 20th week of gestation, 30th week of gestation and at delivery. At these visits, samples of blood are taken in order to measure levels of fasting C-peptide concentration, level of FPG and HbA1c. |
| Intervention type | Supplement |
| Primary outcome measure | FC-peptide concentration is measured by the electrochemiluminescence immunoassay “ECLIA” at baseline, 20 weeks gestation, 30 weeks gestation and at delivery. |
| Secondary outcome measures | Current secondary outcome measures as of 10/09/2020: 1. Glycated hemoglobin (HbA1c) is measured from blood samples taken at baseline, 20 weeks gestation, 30 weeks gestation and at delivery 2. Fasting plasma glucose (FPG) is measured using the fasting plasma glucose test using blood samples taken at baseline, 20 weeks gestation, 30 weeks gestation and at delivery 3. Birth weight of infants is measured by pediatrics after delivery 4. Total lipid profile measured from blood samples (serum) taken at baseline, 2nd and 3rd trimester and at delivery (from mothers and from umbilical cord) _____ Previous secondary outcome measures: 1. Glycated hemoglobin (HbA1c) is measured from blood samples taken at baseline, 20 weeks gestation, 30 weeks gestation and at delivery 2. Fasting plasma glucose (FPG) is measured using the fasting plasma glucose test using blood samples taken at baseline, 20 weeks gestation, 30 weeks gestation and at delivery 3. Birth weight of infants is measured by pediatrics after delivery |
| Overall study start date | 01/12/2013 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Female |
| Target number of participants | 150 individual participants |
| Total final enrolment | 111 |
| Key inclusion criteria | 1. Pregnant women 2. Diagnosis of type 1 diabetes 3. Provision of informed consent 4. Aged between 18-40 years |
| Key exclusion criteria | Type 1 diabetic patients whose pregnancy terminated as preterm delivery |
| Date of first enrolment | 19/12/2013 |
| Date of final enrolment | 30/05/2021 |
Locations
Countries of recruitment
- Croatia
Study participating centre
Zagreb
10000
Croatia
Sponsor information
University/education
Salata 3
Zagreb
1000
Croatia
"ROR" |
https://ror.org/00mv6sv71 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/06/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of results data in a peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Josip Djelmis (josip.djelmis@zg.t-com.hr) and Marina Horvaticek (marina.horvaticek@gmail.com). Data will be shared in agreement with another parties. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2017 | Yes | No | |
| Results article | 01/12/2021 | 10/10/2023 | Yes | No |
Editorial Notes
10/10/2023: Publication reference and total final enrolment added.
10/09/2020: The following changes have been made:
1. The recruitment end date has been changed from 30/05/2019 to 30/05/2021.
2. The overall trial end date has been changed from 30/09/2019 to 31/12/2021.
3. The intention to publish date has been changed from 31/12/2019 to 30/06/2022.
4. The secondary outcome measures have been changed.
5. The target number of participants has been changed from 100 to 150.
16/10/2017: The recruitment end date was changed from 30/05/2016 to 30/05/2019.
12/10/2017: IPD sharing statement and publication reference added.
18/09/2017: The overall trial end date was changed from 30/09/2016 to 30/09/2019.
