Gestational DiabetesNCT05629403
Exclusive Breastfeeding Improves Puerperal Glucose Metabolism in Pregnant Women With Gestational Diabetes Mellitus and Links to Lipids Composition
An observational study of Gestational Diabetes and Breast Feeding, run by Nanjing Medical University at 1 site in China.
Trial summary
Breastfeeding could effectively be associated with a lower risk of future type 2 diabetes (T2D) in women with gestational diabetes mellitus (GDM), but the short-term protective impact of puerperal breastfeeding on maternal metabolic recovery of GDM women remains unascertained. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Gestational Diabetes, Breast Feeding, Lipid Metabolism Disorders
- What is being tested?
- observe
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: women (aged 18-35 years) who delivered live-born infants equal to or greater than 37 weeks of gestation at the Women's Hospital of Nanjing Medical University (Nanjing, China) and were not using medications affecting glucose tolerance, lipid regulation and not planning another pregnancy within the next 2 years were enrolled. All the participants received 75g OGTT at 24-28 weeks of gestation and were diagnosed with GDM based on the IADPSG criteria (International Association of Diabetes and Pregnancy Study Groups Consensus Panel et al.). At 6-8 weeks postpartum, all the participants were administered regularly for a post-natal health check-up to classify the body and genitals basically restored status. Fasting plasma samples were collected to measure plasma glucose, and insulin, and reclassify glucose metabolic status. Frequency and amount of breastmilk feeding and formula feeding for each woman were evaluated by trained research staff via telephone calls.
Who may be able to join
- 18-35 years old;
- gestational age greater than 37 weeks;
- Body Mass Index (BMI) before pregnancy 18.5-28kg/m2;
- Have normal listening and speaking skills, can communicate, and are willing to participate in this study.
Who cannot join
- abnormal glucose metabolism or diabetes has been diagnosed before pregnancy;
- assisted reproduction;
- GDM patients requiring drug treatment;
- The use of blood lipid regulation drugs;
- other pregnancy complications and complications;
- Suffering from heart, malignant tumor, kidney and other major organ diseases;
- associated with neurological dysfunction and cognitive impairment;
- Failure to cooperate with follow-up observers.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternal and child Health Care Hospital
Nanjing, Jiangsu, 21004
About this study
Official title: Women's Hospital of Nanjing Medical University
Breastfeeding could effectively be associated with a lower risk of future type 2 diabetes (T2D) in women with gestational diabetes mellitus (GDM), but the short-term protective impact of puerperal breastfeeding on maternal metabolic recovery of GDM women remains unascertained. The investigators recruited GDM participants at 6-9 weeks postpartum and retrieved clinical diagnoses of GDM from electronic medical records. Feeding patterns were collected via phone calls. Glucose metabolism parameters and lipid profiling were performed on fasting plasma samples collected from patients 6-9 weeks postpartum (20 breastfeeding cases vs. 15 formula feeding cases).
- Being tested
- observe
- Medical subject headings
- Diabetes, Gestational, Breast Feeding, Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observeOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| exclusive breastfeeding | breastfeeding exclusively Receives: Other: observe | |
| formula feeding | formula feeding Receives: Other: observe |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose
glucose (mmol/L) determined with human ELISA kits
Measured: At 6-8 weeks postpartum
insulin
insulin (mU/L) determined with human ELISA kits
Measured: At 6-8 weeks postpartum
c-peptide
c-peptide (ng/m) determined with human ELISA kits
Measured: At 6-8 weeks postpartum
HOMA-IR
fasting glucose and fasting glucose will be combined to report HOMA-IR
Measured: At 6-8 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start1 Sep 2021
- Primary completion30 Mar 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xirong Guo, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629403
- Sponsor's protocol ID
- NanjingMU2022
- Status last verified
- Nov 2022
- First submitted
- 7 Jul 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Hospital of Nanjing Medical University
- ClinicalTrials.gov ID
- NCT05629403
- Acronym / sponsor ID
- NanjingMU2022
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breastfeeding could effectively be associated with a lower risk of future type 2 diabetes (T2D) in women with gestational diabetes mellitus (GDM), but the short-term protective impact of puerperal breastfeeding on maternal metabolic recovery of GDM women remains unascertained. The investigators recruited GDM participants at 6-9 weeks postpartum and retrieved clinical diagnoses of GDM from electronic medical records. Feeding patterns were collected via phone calls. Glucose metabolism parameters and lipid profiling were performed on fasting plasma samples collected from patients 6-9 weeks postpartum (20 breastfeeding cases vs. 15 formula feeding cases).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exclusive breastfeeding | – | Other: observebreastfeeding exclusively |
| formula feeding | – | Other: observeformula feeding |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women (aged 18-35 years) who delivered live-born infants equal to or greater than 37 weeks of gestation at the Women's Hospital of Nanjing Medical University (Nanjing, China) and were not using medications affecting glucose tolerance, lipid regulation and not planning another pregnancy within the next 2 years were enrolled. All the participants received 75g OGTT at 24-28 weeks of gestation and were diagnosed with GDM based on the IADPSG criteria (International Association of Diabetes and Pregnancy Study Groups Consensus Panel et al.). At 6-8 weeks postpartum, all the participants were administered regularly for a post-natal health check-up to classify the body and genitals basically restored status. Fasting plasma samples were collected to measure plasma glucose, and insulin, and reclassify glucose metabolic status. Frequency and amount of breastmilk feeding and formula feeding for each woman were evaluated by trained research staff via telephone calls.
Key inclusion criteria (4 listed)
- 18-35 years old;
- gestational age greater than 37 weeks;
- Body Mass Index (BMI) before pregnancy 18.5-28kg/m2;
- Have normal listening and speaking skills, can communicate, and are willing to participate in this study.
Key exclusion criteria (8 listed)
- abnormal glucose metabolism or diabetes has been diagnosed before pregnancy;
- assisted reproduction;
- GDM patients requiring drug treatment;
- The use of blood lipid regulation drugs;
- other pregnancy complications and complications;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observeno intervention | Other | exclusive breastfeeding, formula feeding |
Primary outcome
glucose
Time frame: At 6-8 weeks postpartum
glucose (mmol/L) determined with human ELISA kits
insulin
Time frame: At 6-8 weeks postpartum
insulin (mU/L) determined with human ELISA kits
c-peptide
Time frame: At 6-8 weeks postpartum
c-peptide (ng/m) determined with human ELISA kits
HOMA-IR
Time frame: At 6-8 weeks postpartum
fasting glucose and fasting glucose will be combined to report HOMA-IR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes and Breast Feeding, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glucose (time frame: At 6-8 weeks postpartum). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.