Gestational Diabetes MellitusNCT03287297
Association Between Dietary Habits and Gestational Diabetes
An observational study of Gestational Diabetes Mellitus, run by Assiut University.
Trial summary
Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance of varying severity with onset or first recognition during pregnancy. The diagnosis of gestational diabetes is important, because of the increased risk of adverse maternal and feto-neonatal outcomes. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- OGTT & HBA1c
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to 1 Dec 2019
- 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 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study will include all pregnant women at 24th to 28th gestational age, who attending to GDM Outpatient Clinic.
Who may be able to join
- include pregnant women at 24th to 28th age of gestation.
Who cannot join
- include pre-gestational diabetic women and pregnant women before and after 24th -28th week of gestation.
Trial locations and contacts
No sites are listed yet.
About this study
Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance of varying severity with onset or first recognition during pregnancy. The diagnosis of gestational diabetes is important, because of the increased risk of adverse maternal and feto-neonatal outcomes. In addition, GDM also confers a future risk of type 2 diabetes to mothers and their fetus. Dietary components associated with GDM risk include macronutrients, micronutrients, and individual foods, such as refined carbohydrates, saturated fats, soft drinks and processed meats. The Pre-pregnancy dietary patterns may affect women risk of developing GDM. A diet high in red and processed meat was associated with a significantly elevated risk.
Read the detailed description
*Aim of the work: To investigate associations between maternal dietary patterns and GDM.
- Patients and Methods:
- Study design: A cross sectional study was conducted.
- Study site: GDM Outpatient Clinic of Assiut University Hospital.
- Study population: The study will include all pregnant women at 24th to 28th gestational age, who attending to GDM Outpatient Clinic during the period of The Study.
- Inclusion criteria include pregnant women at 24th to 28th age of gestation.
- Exclusion criteria include pre-gestational diabetic women and pregnant women before and after 24th -28th week of gestation.
- Instrument: Structured designed questionnaire: Which consists of socio-demographic characteristics, Medical and obstetric history and other risk factors for GDM including previous GDM, family history of diabetes, twins in current pregnancy, history of PCO and macrosomic baby in current or previous pregnancy, also contains information about regularity and frequencies of daily meals taken by the women, and information about food group frequencies per week, food groups like vegetables, fruits, fast food , red and processed meat, fish and seafood, whole grains, cereal fiber, sweetened beverage, dessert food and use of multivitamins.
- Data collection: Direct interview will be done with each participant separately for filling the food frequency questionnaire by the researcher himself during the period from January 2017 to June 2017
- Clinical examination:
- BP (mmHg)
- Pulse
- Body Weight (kg)
- Height (cm)
- BMI
Laboratory Examination
- OGTT (75gm) 2hr
- HBA1c (if Bl. Glucose ≥ 200mg/dl).
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- OGTT & HBA1c
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OGTT & HBA1cDiagnostic test
oral glucose tolerance test \& HBA1c: by measuring glycated hemoglobin
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose Level
Mean difference In Blood Glucose Level Among Cases
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start1 Dec 2017 (estimated)
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mokhtar Abdel-Hameed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287297
- Sponsor's protocol ID
- 17100275
- Status last verified
- Sep 2017
- First submitted
- 16 Sep 2017
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alfadhli EM. Gestational diabetes mellitus. Saudi Med J. 2015 Apr;36(4):399-406. doi: 10.15537/smj.2015.4.10307.
PubMed 25828275Bhatt AA, Dhore PB, Purandare VB, Sayyad MG, Mandal MK, Unnikrishnan AG. Gestational diabetes mellitus in rural population of Western India - Results of a community survey. Indian J Endocrinol Metab. 2015 Jul-Aug;19(4):507-10. doi: 10.4103/2230-8210.159061.
PubMed 26180767Kampmann U, Madsen LR, Skajaa GO, Iversen DS, Moeller N, Ovesen P. Gestational diabetes: A clinical update. World J Diabetes. 2015 Jul 25;6(8):1065-72. doi: 10.4239/wjd.v6.i8.1065.
PubMed 26240703Poomalar GK, Rangaswamy V. A comparison of fasting plasma glucose and glucose challenge test for screening of gestational diabetes mellitus. J Obstet Gynaecol. 2013 Jul;33(5):447-50. doi: 10.3109/01443615.2013.771156.
PubMed 23815193Agarwal MM. Gestational diabetes mellitus: An update on the current international diagnostic criteria. World J Diabetes. 2015 Jun 25;6(6):782-91. doi: 10.4239/wjd.v6.i6.782.
PubMed 26131321Ovesen PG, Jensen DM, Damm P, Rasmussen S, Kesmodel US. Maternal and neonatal outcomes in pregnancies complicated by gestational diabetes. a nation-wide study. J Matern Fetal Neonatal Med. 2015;28(14):1720-4. doi: 10.3109/14767058.2014.966677. Epub 2015 Jan 8.
PubMed 25228278Seshiah V; Diabetes in Pregnancy Study Group. Fifth National Conference of Diabetes in Pregnancy Study Group, India. J Assoc Physicians India. 2010 May;58:329-30. No abstract available.
PubMed 21117358Zhang C, Ning Y. Effect of dietary and lifestyle factors on the risk of gestational diabetes: review of epidemiologic evidence. Am J Clin Nutr. 2011 Dec;94(6 Suppl):1975S-1979S. doi: 10.3945/ajcn.110.001032. Epub 2011 May 25.
PubMed 21613563Zhang C, Schulze MB, Solomon CG, Hu FB. A prospective study of dietary patterns, meat intake and the risk of gestational diabetes mellitus. Diabetologia. 2006 Nov;49(11):2604-13. doi: 10.1007/s00125-006-0422-1. Epub 2006 Sep 7.
PubMed 16957814Qiu C, Zhang C, Gelaye B, Enquobahrie DA, Frederick IO, Williams MA. Gestational diabetes mellitus in relation to maternal dietary heme iron and nonheme iron intake. Diabetes Care. 2011 Jul;34(7):1564-9. doi: 10.2337/dc11-0135.
PubMed 21709295
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Dietary Habits and Gestational Diabetes
- ClinicalTrials.gov ID
- NCT03287297
- Acronym / sponsor ID
- 17100275
- Conditions
- Gestational Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 19 Sep 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.
Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance of varying severity with onset or first recognition during pregnancy. The diagnosis of gestational diabetes is important, because of the increased risk of adverse maternal and feto-neonatal outcomes. In addition, GDM also confers a future risk of type 2 diabetes to mothers and their fetus. Dietary components associated with GDM risk include macronutrients, micronutrients, and individual foods, such as refined carbohydrates, saturated fats, soft drinks and processed meats. The Pre-pregnancy dietary patterns may affect women risk of developing GDM. A diet high in red and processed meat was associated with a significantly elevated risk.
Detailed description
*Aim of the work: To investigate associations between maternal dietary patterns and GDM.
- Patients and Methods:
- Study design: A cross sectional study was conducted.
- Study site: GDM Outpatient Clinic of Assiut University Hospital.
- Study population: The study will include all pregnant women at 24th to 28th gestational age, who attending to GDM Outpatient Clinic during the period of The Study.
- Inclusion criteria include pregnant women at 24th to 28th age of gestation.
- Exclusion criteria include pre-gestational diabetic women and pregnant women before and after 24th -28th week of gestation.
- Instrument: Structured designed questionnaire: Which consists of socio-demographic characteristics, Medical and obstetric history and other risk factors for GDM including previous GDM, family history of diabetes, twins in current pregnancy, history of PCO and macrosomic baby in current or previous pregnancy, also contains information about regularity and frequencies of daily meals taken by the women, and information about food group frequencies per week, food groups like vegetables, fruits, fast food , red and processed meat, fish and seafood, whole grains, cereal fiber, sweetened beverage, dessert food and use of multivitamins.
- Data collection: Direct interview will be done with each participant separately for filling the food frequency questionnaire by the researcher himself during the period from January 2017 to June 2017
- Clinical examination:
- BP (mmHg)
- Pulse
- Body Weight (kg)
- Height (cm)
- BMI
Laboratory Examination
- OGTT (75gm) 2hr
- HBA1c (if Bl. Glucose ≥ 200mg/dl).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will include all pregnant women at 24th to 28th gestational age, who attending to GDM Outpatient Clinic.
Key inclusion criteria (1 listed)
- include pregnant women at 24th to 28th age of gestation.
Key exclusion criteria (1 listed)
- include pre-gestational diabetic women and pregnant women before and after 24th -28th week of gestation.
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 |
|---|---|---|
| OGTT & HBA1coral glucose tolerance test \& HBA1c: by measuring glycated hemoglobin | Diagnostic test | – |
Primary outcome
Blood Glucose Level
Time frame: Baseline
Mean difference In Blood Glucose Level Among Cases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- Background: PubMed 25828275Alfadhli EM. Gestational diabetes mellitus. Saudi Med J. 2015 Apr;36(4):399-406. doi: 10.15537/smj.2015.4.10307.
- Background: PubMed 26180767Bhatt AA, Dhore PB, Purandare VB, Sayyad MG, Mandal MK, Unnikrishnan AG. Gestational diabetes mellitus in rural population of Western India - Results of a community survey. Indian J Endocrinol Metab. 2015 Jul-Aug;19(4):507-10. doi: 10.4103/2230-8210.159061.
- Background: PubMed 26240703Kampmann U, Madsen LR, Skajaa GO, Iversen DS, Moeller N, Ovesen P. Gestational diabetes: A clinical update. World J Diabetes. 2015 Jul 25;6(8):1065-72. doi: 10.4239/wjd.v6.i8.1065.
- Background: PubMed 23815193Poomalar GK, Rangaswamy V. A comparison of fasting plasma glucose and glucose challenge test for screening of gestational diabetes mellitus. J Obstet Gynaecol. 2013 Jul;33(5):447-50. doi: 10.3109/01443615.2013.771156.
- Background: PubMed 26131321Agarwal MM. Gestational diabetes mellitus: An update on the current international diagnostic criteria. World J Diabetes. 2015 Jun 25;6(6):782-91. doi: 10.4239/wjd.v6.i6.782.
- Background: PubMed 25228278Ovesen PG, Jensen DM, Damm P, Rasmussen S, Kesmodel US. Maternal and neonatal outcomes in pregnancies complicated by gestational diabetes. a nation-wide study. J Matern Fetal Neonatal Med. 2015;28(14):1720-4. doi: 10.3109/14767058.2014.966677. Epub 2015 Jan 8.
- Background: PubMed 21117358Seshiah V; Diabetes in Pregnancy Study Group. Fifth National Conference of Diabetes in Pregnancy Study Group, India. J Assoc Physicians India. 2010 May;58:329-30. No abstract available.
- Background: PubMed 21613563Zhang C, Ning Y. Effect of dietary and lifestyle factors on the risk of gestational diabetes: review of epidemiologic evidence. Am J Clin Nutr. 2011 Dec;94(6 Suppl):1975S-1979S. doi: 10.3945/ajcn.110.001032. Epub 2011 May 25.
- Background: PubMed 16957814Zhang C, Schulze MB, Solomon CG, Hu FB. A prospective study of dietary patterns, meat intake and the risk of gestational diabetes mellitus. Diabetologia. 2006 Nov;49(11):2604-13. doi: 10.1007/s00125-006-0422-1. Epub 2006 Sep 7.
- Background: PubMed 21709295Qiu C, Zhang C, Gelaye B, Enquobahrie DA, Frederick IO, Williams MA. Gestational diabetes mellitus in relation to maternal dietary heme iron and nonheme iron intake. Diabetes Care. 2011 Jul;34(7):1564-9. doi: 10.2337/dc11-0135.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes Mellitus, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 20 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nabila Fayek, Professor (0201226341736, nabilaameen13@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose Level (time frame: Baseline). 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 NCT03287297, which also lists 10 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 20 Sep 2017.