Gestational DiabetesNCT03145649
Breast Milk Hormones and Early Infant Growth of Women With Gestational Diabetes Mellitus
An observational study of Gestational Diabetes, run by Peking Union Medical College Hospital.
Trial summary
Background: Breastfeeding has been associated with attenuated risk of obesity and type 2 diabetes in children born to women with diabetes. However, breast milk (BM) components responsible for the protective effects remain to be unveiled. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Dietary therapy or insulin injection
- Type of treatment
- Injection or infusion
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 12 Jan 2010to 16 Jul 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects were recruited consecutively from the obstetric wards at the Peking Union Medical College Hospital and the Beijing Obstetrics and Gynecology Hospital.
Who may be able to join
- Nulliparous women with GDM and healthy women, who intended to exclusively breastfeed their singletons, were recruited consecutively from the obstetric wards at the Peking Union Medical College Hospital and the Beijing Obstetrics and Gynecology Hospital during the 37th gestational week.
Who cannot join
- Pre-pregnancy diabetes, fetal anomaly, gestational hypertension, preeclampsia, fetal growth restriction, ruptured membranes, postpartum glucose abnormalities, and introduction of formula feeding during the follow-ups.
About this study
Background: Breastfeeding has been associated with attenuated risk of obesity and type 2 diabetes in children born to women with diabetes. However, breast milk (BM) components responsible for the protective effects remain to be unveiled.
Objective: To evaluate the hormone concentrations in BM of women with gestational diabetes mellitus (GDM) and their influence on early infant growth.
Read more
Design: The investigators followed nulliparous women with and without GDM and their breastfed term singletons. Women diagnosed with GDM received dietary therapy or insulin injection to maintain euglycemia during pregnancy. Hormone concentrations in BM (i.e., adiponectin, leptin, insulin, and ghrelin) were tested and infant growth was evaluated on days 3, 42 and 90. The investigators compared the hormone concentrations between the GDM and healthy groups, and tested the associations of hormone concentrations with maternal factors (i.e., BMI, plasma glucose concentration, gestational age, and delivery mode) and early infant growth.
Hypothesis: Hormone concentrations in BM could be determined by multiple maternal factors, including metabolic and obstetrical factors. GDM should be a significant influencing factor for hormone concentrations in BM.
Read the detailed description
Subjects Nulliparous women with GDM and healthy women, who intended to exclusively breastfeed their singletons, were recruited consecutively from the obstetric wards at the Peking Union Medical College Hospital and the Beijing Obstetrics and Gynecology Hospital during the 37th gestational week. The exclusion criteria were: pre-pregnancy diabetes, fetal anomaly, gestational hypertension, preeclampsia, fetal growth restriction, ruptured membranes, postpartum glucose abnormalities (see below), and introduction of formula feeding during the follow-ups. Women with plasma glucose>7.8mmol/L in the 1-hour 50g glucose load test (GLT) during the 24th-28th gestational weeks underwent a 3-hour 100g diagnostic oral glucose tolerance test (OGTT) following a 12-hour overnight fast. GDM was diagnosed if two or more plasma glucose reads in the OGTT equaled or exceeded the threshold according to Carpenter and Coustan. All subjects diagnosed with GDM initially received dietary therapy to attain glycemic targets: 3.3-5.6 mmol/L at fasting, 3.3-5.8 mmol/L pre-prandially, 4.4-6.7 mmol/L 2-hours post-prandially, and 4.4-6.7 mmol/L at night. The participants were followed by dietitians to ensure euglycemia, appropriate weight gain, and adequate nutritional intake. The participants who did not attain glycemic targets in 2 weeks after starting the dietary therapy were given insulin via injection. As macronutrients in BM were mainly determined by the maternal glucose metabolic status, the investigators excluded women with postpartum glucose abnormalities, i.e., impaired glucose tolerance (IGT) with the 2-hour plasma glucose between 7.8 and 11.0 mmol/l and type 2 diabetes with the 2-hour plasma glucose ≥11.1 mmol/l in the 75g OGTT on postpartum day 42.
Anthropometric measurements Data was recorded using customized case report forms. Obstetric data, such as glycemic tests, gestational age, and mode of delivery, were retrieved from the medical records. Pre-pregnancy weight was self-reported. Mothers' height was measured twice to the nearest 0.1 cm with a wall-mounted stadiometer. Mothers' weight was measured twice to the nearest 0.1 kg with a medical balance scale before delivery, on postpartum days 42 and 90. The weight, length, and head circumference of the infants were measured at birth, on days 42 and 90. The infants were weighed twice in nude using a precision scale (Seca, CA, USA). Body length and head circumference were measured twice to the nearest 0.1 cm with a length board and non-stretchable measuring tapes (Seca, CA, USA). The mean values of the two readings were used for data analysis.
Milk sample collection, processing, and laboratory tests Colostrum samples were collected between 8 a.m. and 9 a.m. before infant feeding on the third day after delivery. Mature milk, including both foremilk and hindmilk, was delivered and collected from one breast before infant feeding using an electric pump (Medela, Baar, Switzerland) between 2 p.m. and 4 p.m. on days 42 and 90 in the clinics. The milk samples were frozen immediately in sterilized plastic tubes at -80°C. Before quantifying the hormones in BM, the samples were thawed at 4°C, sonicated, and centrifuged. The samples were sonicated using a sonicator (Braun-sonic sonicator, B. Braun, Melsungen, Germany) at 50 watts for 3 bursts with 10-second intervals, and centrifuged at 100,000g for 1 hour at 4°C. The supernatant fat was discarded and the skim milk was used for quantifying adiponectin, leptin, insulin, and ghrelin by ELISA at the Key Laboratory of Endocrinology in the Peking Union Medical College Hospital. The assay had an intra- and inter-assay CV of <5.4 and <8.5% for adiponectin, and <7.4% and <9.3% for leptin, respectively. The insulin assay had no cross-reactivity to proinsulin (<0.05%), and had sensitivity of 0.5 mU/L and an inter-assay CV of <9.0%. Total ghrelin was tested using the total human ghrelin ELISA kit (Millipore, USA). The intra- and inter-assay CVs for the ghrelin assay were <1.9% and <7.7%.
- Conditions
- Gestational Diabetes
- Being tested
- Dietary therapy or insulin injection
- Keywords
- Breast milk, Hormone, Infant growth, Gestational diabetes mellitus
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary therapy or insulin injectionOther
| Study group | Role | What they receive |
|---|---|---|
| Gestational diabetes mellitus | Women with gestational diabetes mellitus and their infants. The blood glucose of women with gestational diabetes mellitus was controlled by dietary therapy or insulin injection. Receives: Other: Dietary therapy or insulin injection | |
| Healthy | Healthy mother-infant dyads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adiponectin in the colostrum
Adiponectin concentration in the colostrum
Measured: Day 3 after delivery
Leptin in the colostrum
Leptin concentration in the colostrum
Measured: Day 3 after delivery
Insulin in the colostrum
Insulin concentration in the colostrum
Measured: Day 3 after delivery
Ghrelin in the colostrum
Ghrelin concentration in the colostrum
Measured: Day 3 after delivery
Adiponectin in the early mature milk
Adiponectin concentration in the mature milk of day 42
Measured: Day 42 after delivery
Leptin in the early mature milk
Leptin concentration in the mature milk of day 42
Measured: Day 42 after delivery
Insulin in the early mature milk
Insulin concentration in the mature milk of day 42
Measured: Day 42 after delivery
Ghrelin in the early mature milk
Ghrelin concentration in the mature milk of day 42
Measured: Day 42 after delivery
Adiponectin in the mature milk
Adiponectin concentration in the mature milk of day 90
Measured: Day 90 after delivery
Leptin in the mature milk
Leptin concentration in the mature milk of day 90
Measured: Day 90 after delivery
Insulin in the mature milk
Insulin concentration in the mature milk of day 90
Measured: Day 90 after delivery
Ghrelin in the mature milk
Ghrelin concentration in the mature milk of day 90
Measured: Day 90 after delivery
Infant birth weight
Infants' weight at birth
Measured: At birth
Infant birth height
Infants' height at birth
Measured: At birth
Infant birth head circumference
Infants' head circumference at birth
Measured: At birth
Infant weight at day 42
Infants' weight at day 42
Measured: Day 42
Infant height at day 42
Infants' height at day 42
Measured: Day 42
Infant head circumference at day 42
Infants' head circumference at day 42
Measured: Day 42
Infant weight at day 90
Infants' weight at day 90
Measured: Day 90
Infant height at day 90
Infants' height at day 90
Measured: Day 90
Infant head circumference at day 90
Infants' head circumference at day 90
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start12 Jan 2010
- Primary completion21 Oct 2010
- Study completion16 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145649
- Sponsor's protocol ID
- D111100000611001
- Status last verified
- May 2017
- First submitted
- 3 May 2017
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dosch HM, Becker DJ. Infant feeding and autoimmune diabetes. Adv Exp Med Biol. 2002;503:133-40. doi: 10.1007/978-1-4615-0559-4_15. No abstract available.
PubMed 12026012Catalano PM, McIntyre HD, Cruickshank JK, McCance DR, Dyer AR, Metzger BE, Lowe LP, Trimble ER, Coustan DR, Hadden DR, Persson B, Hod M, Oats JJ; HAPO Study Cooperative Research Group. The hyperglycemia and adverse pregnancy outcome study: associations of GDM and obesity with pregnancy outcomes. Diabetes Care. 2012 Apr;35(4):780-6. doi: 10.2337/dc11-1790. Epub 2012 Feb 22.
PubMed 22357187Logan KM, Emsley RJ, Jeffries S, Andrzejewska I, Hyde MJ, Gale C, Chappell K, Mandalia S, Santhakumaran S, Parkinson JR, Mills L, Modi N. Development of Early Adiposity in Infants of Mothers With Gestational Diabetes Mellitus. Diabetes Care. 2016 Jun;39(6):1045-51. doi: 10.2337/dc16-0030. Epub 2016 May 12.
PubMed 27208326Gillman MW, Rifas-Shiman S, Berkey CS, Field AE, Colditz GA. Maternal gestational diabetes, birth weight, and adolescent obesity. Pediatrics. 2003 Mar;111(3):e221-6. doi: 10.1542/peds.111.3.e221.
PubMed 12612275Sellers EA, Dean HJ, Shafer LA, Martens PJ, Phillips-Beck W, Heaman M, Prior HJ, Dart AB, McGavock J, Morris M, Torshizi AA, Ludwig S, Shen GX. Exposure to Gestational Diabetes Mellitus: Impact on the Development of Early-Onset Type 2 Diabetes in Canadian First Nations and Non-First Nations Offspring. Diabetes Care. 2016 Dec;39(12):2240-2246. doi: 10.2337/dc16-1148. Epub 2016 Oct 4.
PubMed 27703026Houseknecht KL, McGuire MK, Portocarrero CP, McGuire MA, Beerman K. Leptin is present in human milk and is related to maternal plasma leptin concentration and adiposity. Biochem Biophys Res Commun. 1997 Nov 26;240(3):742-7. doi: 10.1006/bbrc.1997.7736.
PubMed 9398637Weyermann M, Beermann C, Brenner H, Rothenbacher D. Adiponectin and leptin in maternal serum, cord blood, and breast milk. Clin Chem. 2006 Nov;52(11):2095-102. doi: 10.1373/clinchem.2006.071019. Epub 2006 Sep 21.
PubMed 16990422Savino F, Lupica MM, Benetti S, Petrucci E, Liguori SA, Cordero Di Montezemolo L. Adiponectin in breast milk: relation to serum adiponectin concentration in lactating mothers and their infants. Acta Paediatr. 2012 Oct;101(10):1058-62. doi: 10.1111/j.1651-2227.2012.02744.x. Epub 2012 Jul 12.
PubMed 22646778Bronsky J, Mitrova K, Nevoral J, Zamecnik J. Immunoexpression of type-1 adiponectin receptor in the human intestine. Cesk Patol. 2012 Jul;48(3):165-6.
PubMed 23057433Hansen GH, Niels-Christiansen LL, Danielsen EM. Leptin and the obesity receptor (OB-R) in the small intestine and colon: a colocalization study. J Histochem Cytochem. 2008 Jul;56(7):677-85. doi: 10.1369/jhc.2008.950782. Epub 2008 Apr 14.
PubMed 18413648Georgiev IP, Georgieva TM, Pfaffl M, Hammon HM, Blum JW. Insulin-like growth factor and insulin receptors in intestinal mucosa of neonatal calves. J Endocrinol. 2003 Jan;176(1):121-32. doi: 10.1677/joe.0.1760121.
PubMed 12525256Mitrovic O, Cokic V, Dikic D, Budec M, Vignjevic S, Suboticki T, Diklic M, Ajtic R. Ghrelin receptors in human gastrointestinal tract during prenatal and early postnatal development. Peptides. 2014 Jul;57:1-11. doi: 10.1016/j.peptides.2014.04.010. Epub 2014 Apr 23.
PubMed 24768902Correa A, Bardenheier B, Elixhauser A, Geiss LS, Gregg E. Trends in prevalence of diabetes among delivery hospitalizations, United States, 1993-2009. Matern Child Health J. 2015 Mar;19(3):635-42. doi: 10.1007/s10995-014-1553-5.
PubMed 24996952Chamberlain C, Banks E, Joshy G, Diouf I, Oats JJ, Gubhaju L, Eades S. Prevalence of gestational diabetes mellitus among Indigenous women and comparison with non-Indigenous Australian women: 1990-2009. Aust N Z J Obstet Gynaecol. 2014 Oct;54(5):433-40. doi: 10.1111/ajo.12213. Epub 2014 Apr 29.
PubMed 24773552van Beusekom CM, Zeegers TA, Martini IA, Velvis HJ, Visser GH, van Doormaal JJ, Muskiet FA. Milk of patients with tightly controlled insulin-dependent diabetes mellitus has normal macronutrient and fatty acid composition. Am J Clin Nutr. 1993 Jun;57(6):938-43. doi: 10.1093/ajcn/57.6.938.
PubMed 8503365
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Milk Hormones and Early Infant Growth of Women With Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03145649
- Acronym / sponsor ID
- D111100000611001
- Conditions
- Gestational Diabetes
- Keywords
- Breast milk, Hormone, Infant growth, Gestational diabetes mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 12 Jan 2010 (actual)
- Primary completion
- 21 Oct 2010 (actual)
- Study completion
- 16 Jul 2011 (actual)
- First posted
- 9 May 2017 (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.
Background: Breastfeeding has been associated with attenuated risk of obesity and type 2 diabetes in children born to women with diabetes. However, breast milk (BM) components responsible for the protective effects remain to be unveiled.
Objective: To evaluate the hormone concentrations in BM of women with gestational diabetes mellitus (GDM) and their influence on early infant growth.
Design: The investigators followed nulliparous women with and without GDM and their breastfed term singletons. Women diagnosed with GDM received dietary therapy or insulin injection to maintain euglycemia during pregnancy. Hormone concentrations in BM (i.e., adiponectin, leptin, insulin, and ghrelin) were tested and infant growth was evaluated on days 3, 42 and 90. The investigators compared the hormone concentrations between the GDM and healthy groups, and tested the associations of hormone concentrations with maternal factors (i.e., BMI, plasma glucose concentration, gestational age, and delivery mode) and early infant growth.
Hypothesis: Hormone concentrations in BM could be determined by multiple maternal factors, including metabolic and obstetrical factors. GDM should be a significant influencing factor for hormone concentrations in BM.
Detailed description
Subjects Nulliparous women with GDM and healthy women, who intended to exclusively breastfeed their singletons, were recruited consecutively from the obstetric wards at the Peking Union Medical College Hospital and the Beijing Obstetrics and Gynecology Hospital during the 37th gestational week. The exclusion criteria were: pre-pregnancy diabetes, fetal anomaly, gestational hypertension, preeclampsia, fetal growth restriction, ruptured membranes, postpartum glucose abnormalities (see below), and introduction of formula feeding during the follow-ups. Women with plasma glucose>7.8mmol/L in the 1-hour 50g glucose load test (GLT) during the 24th-28th gestational weeks underwent a 3-hour 100g diagnostic oral glucose tolerance test (OGTT) following a 12-hour overnight fast. GDM was diagnosed if two or more plasma glucose reads in the OGTT equaled or exceeded the threshold according to Carpenter and Coustan. All subjects diagnosed with GDM initially received dietary therapy to attain glycemic targets: 3.3-5.6 mmol/L at fasting, 3.3-5.8 mmol/L pre-prandially, 4.4-6.7 mmol/L 2-hours post-prandially, and 4.4-6.7 mmol/L at night. The participants were followed by dietitians to ensure euglycemia, appropriate weight gain, and adequate nutritional intake. The participants who did not attain glycemic targets in 2 weeks after starting the dietary therapy were given insulin via injection. As macronutrients in BM were mainly determined by the maternal glucose metabolic status, the investigators excluded women with postpartum glucose abnormalities, i.e., impaired glucose tolerance (IGT) with the 2-hour plasma glucose between 7.8 and 11.0 mmol/l and type 2 diabetes with the 2-hour plasma glucose ≥11.1 mmol/l in the 75g OGTT on postpartum day 42.
Anthropometric measurements Data was recorded using customized case report forms. Obstetric data, such as glycemic tests, gestational age, and mode of delivery, were retrieved from the medical records. Pre-pregnancy weight was self-reported. Mothers' height was measured twice to the nearest 0.1 cm with a wall-mounted stadiometer. Mothers' weight was measured twice to the nearest 0.1 kg with a medical balance scale before delivery, on postpartum days 42 and 90. The weight, length, and head circumference of the infants were measured at birth, on days 42 and 90. The infants were weighed twice in nude using a precision scale (Seca, CA, USA). Body length and head circumference were measured twice to the nearest 0.1 cm with a length board and non-stretchable measuring tapes (Seca, CA, USA). The mean values of the two readings were used for data analysis.
Milk sample collection, processing, and laboratory tests Colostrum samples were collected between 8 a.m. and 9 a.m. before infant feeding on the third day after delivery. Mature milk, including both foremilk and hindmilk, was delivered and collected from one breast before infant feeding using an electric pump (Medela, Baar, Switzerland) between 2 p.m. and 4 p.m. on days 42 and 90 in the clinics. The milk samples were frozen immediately in sterilized plastic tubes at -80°C. Before quantifying the hormones in BM, the samples were thawed at 4°C, sonicated, and centrifuged. The samples were sonicated using a sonicator (Braun-sonic sonicator, B. Braun, Melsungen, Germany) at 50 watts for 3 bursts with 10-second intervals, and centrifuged at 100,000g for 1 hour at 4°C. The supernatant fat was discarded and the skim milk was used for quantifying adiponectin, leptin, insulin, and ghrelin by ELISA at the Key Laboratory of Endocrinology in the Peking Union Medical College Hospital. The assay had an intra- and inter-assay CV of <5.4 and <8.5% for adiponectin, and <7.4% and <9.3% for leptin, respectively. The insulin assay had no cross-reactivity to proinsulin (<0.05%), and had sensitivity of 0.5 mU/L and an inter-assay CV of <9.0%. Total ghrelin was tested using the total human ghrelin ELISA kit (Millipore, USA). The intra- and inter-assay CVs for the ghrelin assay were <1.9% and <7.7%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gestational diabetes mellitus | – | Other: Dietary therapy or insulin injectionWomen with gestational diabetes mellitus and their infants. The blood glucose of women with gestational diabetes mellitus was controlled by dietary therapy or insulin injection. |
| Healthy | – | –Healthy mother-infant dyads |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects were recruited consecutively from the obstetric wards at the Peking Union Medical College Hospital and the Beijing Obstetrics and Gynecology Hospital.
Key inclusion criteria (1 listed)
- Nulliparous women with GDM and healthy women, who intended to exclusively breastfeed their singletons, were recruited consecutively from the obstetric wards at the Peking Union Medical College Hospital and the Beijing Obstetrics and Gynecology Hospital during the 37th gestational week.
Key exclusion criteria (1 listed)
- Pre-pregnancy diabetes, fetal anomaly, gestational hypertension, preeclampsia, fetal growth restriction, ruptured membranes, postpartum glucose abnormalities, and introduction of formula feeding during the follow-ups.
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 |
|---|---|---|
| Dietary therapy or insulin injection | Other | Gestational diabetes mellitus |
Primary outcome
Adiponectin in the colostrum
Time frame: Day 3 after delivery
Adiponectin concentration in the colostrum
Leptin in the colostrum
Time frame: Day 3 after delivery
Leptin concentration in the colostrum
Insulin in the colostrum
Time frame: Day 3 after delivery
Insulin concentration in the colostrum
Ghrelin in the colostrum
Time frame: Day 3 after delivery
Ghrelin concentration in the colostrum
Adiponectin in the early mature milk
Time frame: Day 42 after delivery
Adiponectin concentration in the mature milk of day 42
Leptin in the early mature milk
Time frame: Day 42 after delivery
Leptin concentration in the mature milk of day 42
Insulin in the early mature milk
Time frame: Day 42 after delivery
Insulin concentration in the mature milk of day 42
Ghrelin in the early mature milk
Time frame: Day 42 after delivery
Ghrelin concentration in the mature milk of day 42
Adiponectin in the mature milk
Time frame: Day 90 after delivery
Adiponectin concentration in the mature milk of day 90
Leptin in the mature milk
Time frame: Day 90 after delivery
Leptin concentration in the mature milk of day 90
Insulin in the mature milk
Time frame: Day 90 after delivery
Insulin concentration in the mature milk of day 90
Ghrelin in the mature milk
Time frame: Day 90 after delivery
Ghrelin concentration in the mature milk of day 90
Infant birth weight
Time frame: At birth
Infants' weight at birth
Infant birth height
Time frame: At birth
Infants' height at birth
Infant birth head circumference
Time frame: At birth
Infants' head circumference at birth
Infant weight at day 42
Time frame: Day 42
Infants' weight at day 42
Infant height at day 42
Time frame: Day 42
Infants' height at day 42
Infant head circumference at day 42
Time frame: Day 42
Infants' head circumference at day 42
Infant weight at day 90
Time frame: Day 90
Infants' weight at day 90
Infant height at day 90
Time frame: Day 90
Infants' height at day 90
Infant head circumference at day 90
Time frame: Day 90
Infants' head circumference at day 90
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 9 May 2017.
- Background: PubMed 12026012Dosch HM, Becker DJ. Infant feeding and autoimmune diabetes. Adv Exp Med Biol. 2002;503:133-40. doi: 10.1007/978-1-4615-0559-4_15. No abstract available.
- Background: PubMed 22357187Catalano PM, McIntyre HD, Cruickshank JK, McCance DR, Dyer AR, Metzger BE, Lowe LP, Trimble ER, Coustan DR, Hadden DR, Persson B, Hod M, Oats JJ; HAPO Study Cooperative Research Group. The hyperglycemia and adverse pregnancy outcome study: associations of GDM and obesity with pregnancy outcomes. Diabetes Care. 2012 Apr;35(4):780-6. doi: 10.2337/dc11-1790. Epub 2012 Feb 22.
- Background: PubMed 27208326Logan KM, Emsley RJ, Jeffries S, Andrzejewska I, Hyde MJ, Gale C, Chappell K, Mandalia S, Santhakumaran S, Parkinson JR, Mills L, Modi N. Development of Early Adiposity in Infants of Mothers With Gestational Diabetes Mellitus. Diabetes Care. 2016 Jun;39(6):1045-51. doi: 10.2337/dc16-0030. Epub 2016 May 12.
- Background: PubMed 12612275Gillman MW, Rifas-Shiman S, Berkey CS, Field AE, Colditz GA. Maternal gestational diabetes, birth weight, and adolescent obesity. Pediatrics. 2003 Mar;111(3):e221-6. doi: 10.1542/peds.111.3.e221.
- Background: PubMed 27703026Sellers EA, Dean HJ, Shafer LA, Martens PJ, Phillips-Beck W, Heaman M, Prior HJ, Dart AB, McGavock J, Morris M, Torshizi AA, Ludwig S, Shen GX. Exposure to Gestational Diabetes Mellitus: Impact on the Development of Early-Onset Type 2 Diabetes in Canadian First Nations and Non-First Nations Offspring. Diabetes Care. 2016 Dec;39(12):2240-2246. doi: 10.2337/dc16-1148. Epub 2016 Oct 4.
- Background: PubMed 9398637Houseknecht KL, McGuire MK, Portocarrero CP, McGuire MA, Beerman K. Leptin is present in human milk and is related to maternal plasma leptin concentration and adiposity. Biochem Biophys Res Commun. 1997 Nov 26;240(3):742-7. doi: 10.1006/bbrc.1997.7736.
- Background: PubMed 16990422Weyermann M, Beermann C, Brenner H, Rothenbacher D. Adiponectin and leptin in maternal serum, cord blood, and breast milk. Clin Chem. 2006 Nov;52(11):2095-102. doi: 10.1373/clinchem.2006.071019. Epub 2006 Sep 21.
- Background: PubMed 22646778Savino F, Lupica MM, Benetti S, Petrucci E, Liguori SA, Cordero Di Montezemolo L. Adiponectin in breast milk: relation to serum adiponectin concentration in lactating mothers and their infants. Acta Paediatr. 2012 Oct;101(10):1058-62. doi: 10.1111/j.1651-2227.2012.02744.x. Epub 2012 Jul 12.
- Background: PubMed 23057433Bronsky J, Mitrova K, Nevoral J, Zamecnik J. Immunoexpression of type-1 adiponectin receptor in the human intestine. Cesk Patol. 2012 Jul;48(3):165-6.
- Background: PubMed 18413648Hansen GH, Niels-Christiansen LL, Danielsen EM. Leptin and the obesity receptor (OB-R) in the small intestine and colon: a colocalization study. J Histochem Cytochem. 2008 Jul;56(7):677-85. doi: 10.1369/jhc.2008.950782. Epub 2008 Apr 14.
- Background: PubMed 12525256Georgiev IP, Georgieva TM, Pfaffl M, Hammon HM, Blum JW. Insulin-like growth factor and insulin receptors in intestinal mucosa of neonatal calves. J Endocrinol. 2003 Jan;176(1):121-32. doi: 10.1677/joe.0.1760121.
- Background: PubMed 24768902Mitrovic O, Cokic V, Dikic D, Budec M, Vignjevic S, Suboticki T, Diklic M, Ajtic R. Ghrelin receptors in human gastrointestinal tract during prenatal and early postnatal development. Peptides. 2014 Jul;57:1-11. doi: 10.1016/j.peptides.2014.04.010. Epub 2014 Apr 23.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes, run by Peking Union Medical College Hospital.
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 1 inclusion and 1 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 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Adiponectin in the colostrum (time frame: Day 3 after delivery). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03145649, which also lists 36 linked publications.
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 9 May 2017.