Gestational Diabetes MellitusNCT07636577
Nutrition Counseling, Diet Quality, and Advanced Glycation End Products in Gestational Diabetes
A study testing Structured Nutrition Counseling in people with Gestational Diabetes Mellitus and Pregnancy, run by Istanbul Saglik Bilimleri University.
Trial summary
This study will evaluate the relationship between structured nutrition counseling, diet quality, and advanced glycation end products in pregnant women with gestational diabetes mellitus and women with normal glucose tolerance. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus, Pregnancy
- What is being tested?
- Structured Nutrition Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women aged 18 to 35 years
- Singleton and first pregnancy
- Gestational age between 24 and 28 weeks at enrollment
- Diagnosis of gestational diabetes mellitus or normal glucose tolerance
- Not using insulin therapy
- Stopped smoking at least 3 months before enrollment and not using alcohol
- Willingness to participate in the study
- Ability to provide written informed consent
Who cannot join
- Current use of insulin therapy
- Active smoking
- Alcohol use
- Refusal or inability to provide written informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Relationship Between Nutrition Counseling in Gestational Diabetes Mellitus and Diet Quality and Advanced Glycation End Products
This study will evaluate the relationship between structured nutrition counseling, diet quality, and advanced glycation end products in pregnant women with gestational diabetes mellitus and women with normal glucose tolerance. Participants will be assigned to either a structured nutrition counseling group or a standard care group according to glucose tolerance status. The counseling program will include education and follow-up on healthy eating during pregnancy, gestational diabetes management, portion control, food choices, meal planning, and cooking methods. Diet quality, dietary habits, biochemical parameters, advanced glycation end products, gestational weight gain, and fetal outcomes will be assessed during follow-up.
- Conditions
- Gestational Diabetes Mellitus, Pregnancy
- Being tested
- Structured Nutrition Counseling, Standard Care
- Keywords
- Advanced Glycation End Products, Diet Quality, Nutrition Counseling, Dietary Habits, Highly Processed Food Consumption
- Medical subject headings
- Diabetes, Gestational, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Nutrition CounselingBehavioural
A dietitian-led structured nutrition counseling, education, and follow-up program provided in addition to standard care. The program includes education on pregnancy, gestational diabetes mellitus, adequate and balanced nutrition, appropriate gestational weight gain, portion control, low glycemic index food choices, reduction of highly processed foods, healthy cooking methods, carbohydrate intake, and meal planning. Follow-up will be conducted at least every two weeks by telephone, online, or face-to-face sessions. Dietary records and weight changes will be reviewed, and individualized feedback and motivational support will be provided.
Standard CareOther
Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.
| Study group | Role | What they receive |
|---|---|---|
| NGT-Control | Active comparator | Pregnant women with normal glucose tolerance receiving standard obstetric care and routine dietitian consultation. Receives: Other: Standard Care |
| NGT-Intervention | Experimental | Pregnant women with normal glucose tolerance receiving standard obstetric care plus structured nutrition counseling. Receives: Behavioral: Structured Nutrition Counseling; Other: Standard Care |
| GDM-Control | Active comparator | Pregnant women with gestational diabetes mellitus receiving standard gestational diabetes management and routine dietitian consultation. Receives: Other: Standard Care |
| GDM-Intervention | Experimental | Pregnant women with gestational diabetes mellitus receiving standard gestational diabetes management plus structured nutrition counseling. Receives: Behavioral: Structured Nutrition Counseling; Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet Quality Score
Diet quality will be assessed using the Diet Quality Index-International based on three-day food records. The score ranges from 0 to 100, with higher scores indicating better diet quality.
Measured: Baseline at 24-28 weeks of gestation and final assessment at 32-36 weeks of gestation
Serum Advanced Glycation End Products Level
Serum advanced glycation end products levels will be measured using serum samples obtained from residual blood collected during routine clinical tests. Levels will be evaluated in relation to glucose tolerance status, nutrition counseling, diet quality, and dietary behaviors.
Measured: Final assessment at approximately 32-36 weeks of gestation
Secondary outcomes (6)
Highly Processed Food Consumption Score
Highly processed food consumption will be assessed using the short screening questionnaire of highly processed food consumption. Higher scores indicate higher consumption of highly processed foods.
Measured: Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation
Dietary Habits and Cooking Methods
Dietary habits and cooking methods will be assessed using a structured questionnaire including meal frequency, skipped meals, snacking habits, food preferences, cooking methods, and types of oils used in food preparation.
Measured: Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation
Gestational Weight Gain
Gestational weight gain will be evaluated using maternal body weight measurements recorded during pregnancy follow-up.
Measured: Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation
Birth Weight
Infant birth weight will be recorded in grams after delivery from obstetric and neonatal records.
Measured: At delivery
Gestational Age at Birth
Gestational age at birth will be recorded in completed weeks after delivery from obstetric records.
Measured: At delivery
Congenital Anomaly Status
The presence or absence of congenital anomaly will be recorded after delivery from obstetric and neonatal records.
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be allocated into four parallel groups according to glucose tolerance status and intervention allocation: NGT-C, normal glucose tolerance control group receiving standard obstetric care and routine dietitian consultation; NGT-I, normal glucose tolerance intervention group receiving standard care plus structured nutrition counseling; GDM-C, gestational diabetes mellitus control group receiving standard gestational diabetes management and routine dietitian consultation; and GDM-I, gestational diabetes mellitus intervention group receiving standard gestational diabetes management plus structured nutrition counseling.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyzanur Çamlıbel, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636577
- Sponsor's protocol ID
- 25-49
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study includes sensitive health data from pregnant women. Data will be stored and analyzed in coded and anonymized form in accordance with the informed consent and ethics committee approval.
Publications
Sisay M, Edessa D, Ali T, Mekuria AN, Gebrie A. The relationship between advanced glycation end products and gestational diabetes: A systematic review and meta-analysis. PLoS One. 2020 Oct 21;15(10):e0240382. doi: 10.1371/journal.pone.0240382. eCollection 2020.
PubMed 33085688
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Nutrition Counseling in Gestational Diabetes Mellitus and Diet Quality and Advanced Glycation End Products
- ClinicalTrials.gov ID
- NCT07636577
- Acronym / sponsor ID
- 25-49
- Conditions
- Gestational Diabetes Mellitus, Pregnancy
- Keywords
- Advanced Glycation End Products, Diet Quality, Nutrition Counseling, Dietary Habits, Highly Processed Food Consumption
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 9 Jun 2026 (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.
This study will evaluate the relationship between structured nutrition counseling, diet quality, and advanced glycation end products in pregnant women with gestational diabetes mellitus and women with normal glucose tolerance. Participants will be assigned to either a structured nutrition counseling group or a standard care group according to glucose tolerance status. The counseling program will include education and follow-up on healthy eating during pregnancy, gestational diabetes management, portion control, food choices, meal planning, and cooking methods. Diet quality, dietary habits, biochemical parameters, advanced glycation end products, gestational weight gain, and fetal outcomes will be assessed during follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be allocated into four parallel groups according to glucose tolerance status and intervention allocation: NGT-C, normal glucose tolerance control group receiving standard obstetric care and routine dietitian consultation; NGT-I, normal glucose tolerance intervention group receiving standard care plus structured nutrition counseling; GDM-C, gestational diabetes mellitus control group receiving standard gestational diabetes management and routine dietitian consultation; and GDM-I, gestational diabetes mellitus intervention group receiving standard gestational diabetes management plus structured nutrition counseling.
| Arm | Type | Receives |
|---|---|---|
| NGT-Control | Active comparator | Other: Standard CarePregnant women with normal glucose tolerance receiving standard obstetric care and routine dietitian consultation. |
| NGT-Intervention | Experimental | Behavioral: Structured Nutrition Counseling, Other: Standard CarePregnant women with normal glucose tolerance receiving standard obstetric care plus structured nutrition counseling. |
| GDM-Control | Active comparator | Other: Standard CarePregnant women with gestational diabetes mellitus receiving standard gestational diabetes management and routine dietitian consultation. |
| GDM-Intervention | Experimental | Behavioral: Structured Nutrition Counseling, Other: Standard CarePregnant women with gestational diabetes mellitus receiving standard gestational diabetes management plus structured nutrition counseling. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Pregnant women aged 18 to 35 years
- Singleton and first pregnancy
- Gestational age between 24 and 28 weeks at enrollment
- Diagnosis of gestational diabetes mellitus or normal glucose tolerance
- Not using insulin therapy
Key exclusion criteria (4 listed)
- Current use of insulin therapy
- Active smoking
- Alcohol use
- Refusal or inability to provide written informed consent
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 |
|---|---|---|
| Structured Nutrition CounselingA dietitian-led structured nutrition counseling, education, and follow-up program provided in addition to standard care. The program includes education on pregnancy, gestational diabetes mellitus, adequate and balanced nutrition, appropriate gestational weight gain, portion control, low glycemic index food choices, reduction of highly processed foods, healthy cooking methods, carbohydrate intake, and meal planning. Follow-up will be conducted at least every two weeks by telephone, online, or face-to-face sessions. Dietary records and weight changes will be reviewed, and individualized feedback and motivational support will be provided. | Behavioural | GDM-Intervention, NGT-Intervention |
| Standard CareStandard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation. | Other | GDM-Control, GDM-Intervention, NGT-Control, NGT-Intervention |
Primary outcome
Diet Quality Score
Time frame: Baseline at 24-28 weeks of gestation and final assessment at 32-36 weeks of gestation
Diet quality will be assessed using the Diet Quality Index-International based on three-day food records. The score ranges from 0 to 100, with higher scores indicating better diet quality.
Serum Advanced Glycation End Products Level
Time frame: Final assessment at approximately 32-36 weeks of gestation
Serum advanced glycation end products levels will be measured using serum samples obtained from residual blood collected during routine clinical tests. Levels will be evaluated in relation to glucose tolerance status, nutrition counseling, diet quality, and dietary behaviors.
6 secondary outcomes
Highly Processed Food Consumption Score
Time frame: Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation
Dietary Habits and Cooking Methods
Time frame: Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation
Gestational Weight Gain
Time frame: Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation
Birth Weight
Time frame: At delivery
Gestational Age at Birth
Time frame: At delivery
Congenital Anomaly Status
Time frame: At delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Results publication: PubMed 33085688Sisay M, Edessa D, Ali T, Mekuria AN, Gebrie A. The relationship between advanced glycation end products and gestational diabetes: A systematic review and meta-analysis. PLoS One. 2020 Oct 21;15(10):e0240382. doi: 10.1371/journal.pone.0240382. eCollection 2020.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study includes sensitive health data from pregnant women. Data will be stored and analyzed in coded and anonymized form in accordance with the informed consent and ethics committee approval.
Related trials for Gestational Diabetes Mellitus
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
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.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Nutrition Counseling in people with Gestational Diabetes Mellitus and Pregnancy, run by Istanbul Saglik Bilimleri 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 8 inclusion and 4 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: opening soon, as of the sponsor's last update on 9 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BEYZANUR ÇAMLIBEL, Dietitian / PhD Candidate (+90 541 656 78 19, beyzanur.cmlbl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet Quality Score (time frame: Baseline at 24-28 weeks of gestation and final assessment at 32-36 weeks of gestation). The study lists 2 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 NCT07636577, which also lists 1 linked publication.
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 Jun 2026.