Gestational DiabetesNCT05096078
The Effect of Circuit Exercise Program in Gestational Diabetes
A study testing Diet and Exercise in people with Gestational Diabetes, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Gestational diabetes (GDM) is defined as 'pregnancy-onset or first noticed glucose intolerance'. The aim of this study is to investigate the effect of circuit exercise program applied in addition to diet therapy on cognitive function, functional exercise capacity, mobility, depression and quality of life in women with… 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
- What is being tested?
- Diet and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Oct 2020to Jun 2022
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- being diagnosed with gestational DM
- being between the ages of 18-35
- being in 24-32 weeks of pregnancy
- being inactive physical activity level - (<300 MET weeks/day)
Who cannot join
- Diagnosed with diabetes before pregnancy
- have given birth before
- Multiple Pregnancy (>2)
- Intrauterine growth restriction
- Preeclampsia
- having high risk of preterm labor and on strict bed rest
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- treatment with insulin or oral hypoglycemic agents during pregnancy
- Other significant severe or poorly controlled medical conditions (thyroid disease, cardio-respiratory disorders, ...)
- taking medications that affect cognitive function, including corticosteroids, anti-depressants, or anti-epileptics
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34815
About this study
Official title: The Effect of Circuit Exercise Program on Cognitive Function, Functional Exercise Capacity, Mobility, Depression and Quality of Life in Women With Gestational Diabetes
Gestational diabetes (GDM) is defined as 'pregnancy-onset or first noticed glucose intolerance'. The aim of this study is to investigate the effect of circuit exercise program applied in addition to diet therapy on cognitive function, functional exercise capacity, mobility, depression and quality of life in women with gestational diabetes. 60 female participants between the ages of 18-35 who meet the inclusion criteria will be included in the study. Participants will be randomly divided into 2 groups as diet group (n=30) and exercise group (n=30). All participants will receive GDM-specific dietary therapy for 6 weeks. In addition to diet therapy, individuals in the exercise group will be given a circuit exercise program for 6 weeks. Participants will be evaluated for blood values, cognitive status and functionality at the baseline and 6 weeks later.
- Conditions
- Gestational Diabetes
- Being tested
- Diet, Exercise
- Keywords
- Gestational diabetes, Circuit Exercise, Cognition
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Special diet program for gestational diabetes
ExerciseOther
The circuit exercise program will consist of a medium-intensity circuit training for 50 minutes, 3 days a week, detailing the main muscle groups of the patients (chest, back, biceps, triceps, deltoid, quadriceps, thigh and calf muscles). Exercise intensity will be monitored using Borg's scale of perceived exertion, with a target intensity of 12 to 14. 8 exercises will be given in a continuous, circuit-type manner with short 1-minute rests.
| Study group | Role | What they receive |
|---|---|---|
| Diet Group | Active comparator | Individuals will receive only dietary treatment that the dietitian deems appropriate for 6 weeks. Receives: Other: Diet |
| Exercise Group | Experimental | In addition to the 6-week diet program that the dietitian deems appropriate, a circuit exercise program will be applied for 6 weeks. The circuit exercise program will consist of a medium-intensity circuit training for 50 minutes, 3 days a week, detailing the main muscle groups of the patients (chest, back, biceps, triceps, deltoid, quadriceps, thigh and calf muscles). Exercise intensity will be monitored using Borg's scale of perceived exertion, with a target intensity of 12 to 14. 8 exercises will be given in a continuous, circuit-type manner with short 1-minute rests. Receives: Other: Diet; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood count test 1
Fasting blood glucose (FBG) value will be recorded.
Measured: 6 weeks after baseline
Blood count test 2
Postprandial blood glucose (PBG) value will be recorded.
Measured: 6 weeks after baseline
Blood count test 3
HbA1c value will be recorded.
Measured: 6 weeks after baseline
Blood count test 4
Total cholesterol (T-col) value will be recorded.
Measured: 6 weeks after baseline
Blood count test 5
High-density lipoprotein cholesterol (HDL) value will be recorded.
Measured: 6 weeks after baseline
Blood count test 6
Low-density lipoprotein cholesterol (LDL) value will be recorded.
Measured: 6 weeks after baseline
Blood count test 7
Insulin value will be recorded.
Measured: 6 weeks after baseline
Blood count test 8
Triglyceride (TG) value will be recorded.
Measured: 6 weeks after baseline
Secondary outcomes (2)
Montreal Cognitive Assessment Scale
It is a screening scale developed to evaluate the early stages of cognitive impairment. Min score is 0, max score is 30. High scores mean a better outcome.
Measured: 6 weeks after baseline
WMS Number Range Test
In the forward number range, the patient is asked to repeat the numbers told to her in the same order, and in the backward number range, the patient is asked to repeat the said numbers from the end to the beginning. High scores mean a better outcome.
Measured: 6 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start16 Oct 2020
- Primary completionMar 2022 (estimated)
- Study completionJun 2022 (estimated)
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 Istanbul Medipol University 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miray Budak, Istanbul Medipol University Hospital
- Investigators
- Miray BUDAK, PhD, Study director, Medipol UniversitySaadet Turhan, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096078
- Sponsor's protocol ID
- GestationalDM.Exer.Cog.
- Status last verified
- Mar 2022
- First submitted
- 15 Oct 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Circuit Exercise Program on Cognitive Function, Functional Exercise Capacity, Mobility, Depression and Quality of Life in Women With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT05096078
- Acronym / sponsor ID
- GestationalDM.Exer.Cog.
- Conditions
- Gestational Diabetes
- Keywords
- Gestational diabetes, Circuit Exercise, Cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 27 Oct 2021 (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 (GDM) is defined as 'pregnancy-onset or first noticed glucose intolerance'. The aim of this study is to investigate the effect of circuit exercise program applied in addition to diet therapy on cognitive function, functional exercise capacity, mobility, depression and quality of life in women with gestational diabetes. 60 female participants between the ages of 18-35 who meet the inclusion criteria will be included in the study. Participants will be randomly divided into 2 groups as diet group (n=30) and exercise group (n=30). All participants will receive GDM-specific dietary therapy for 6 weeks. In addition to diet therapy, individuals in the exercise group will be given a circuit exercise program for 6 weeks. Participants will be evaluated for blood values, cognitive status and functionality at the baseline and 6 weeks later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet Group | Active comparator | Other: DietIndividuals will receive only dietary treatment that the dietitian deems appropriate for 6 weeks. |
| Exercise Group | Experimental | Other: Diet, Other: ExerciseIn addition to the 6-week diet program that the dietitian deems appropriate, a circuit exercise program will be applied for 6 weeks. The circuit exercise program will consist of a medium-intensity circuit training for 50 minutes, 3 days a week, detailing the main muscle groups of the patients (chest, back, biceps, triceps, deltoid, quadriceps, thigh and calf muscles). Exercise intensity will be monitored using Borg's scale of perceived exertion, with a target intensity of 12 to 14. 8 exercises will be given in a continuous, circuit-type manner with short 1-minute rests. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- being diagnosed with gestational DM
- being between the ages of 18-35
- being in 24-32 weeks of pregnancy
- being inactive physical activity level - (<300 MET weeks/day)
Key exclusion criteria (9 listed)
- Diagnosed with diabetes before pregnancy
- have given birth before
- Multiple Pregnancy (>2)
- Intrauterine growth restriction
- Preeclampsia
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 |
|---|---|---|
| DietSpecial diet program for gestational diabetes | Other | Diet Group, Exercise Group |
| ExerciseThe circuit exercise program will consist of a medium-intensity circuit training for 50 minutes, 3 days a week, detailing the main muscle groups of the patients (chest, back, biceps, triceps, deltoid, quadriceps, thigh and calf muscles). Exercise intensity will be monitored using Borg's scale of perceived exertion, with a target intensity of 12 to 14. 8 exercises will be given in a continuous, circuit-type manner with short 1-minute rests. | Other | Exercise Group |
Primary outcome
Blood count test 1
Time frame: 6 weeks after baseline
Fasting blood glucose (FBG) value will be recorded.
Blood count test 2
Time frame: 6 weeks after baseline
Postprandial blood glucose (PBG) value will be recorded.
Blood count test 3
Time frame: 6 weeks after baseline
HbA1c value will be recorded.
Blood count test 4
Time frame: 6 weeks after baseline
Total cholesterol (T-col) value will be recorded.
Blood count test 5
Time frame: 6 weeks after baseline
High-density lipoprotein cholesterol (HDL) value will be recorded.
Blood count test 6
Time frame: 6 weeks after baseline
Low-density lipoprotein cholesterol (LDL) value will be recorded.
Blood count test 7
Time frame: 6 weeks after baseline
Insulin value will be recorded.
Blood count test 8
Time frame: 6 weeks after baseline
Triglyceride (TG) value will be recorded.
2 secondary outcomes
Montreal Cognitive Assessment Scale
Time frame: 6 weeks after baseline
WMS Number Range Test
Time frame: 6 weeks after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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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.
Miray BUDAK, PhD study director
Medipol University
Saadet Turhan principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and Exercise in people with Gestational Diabetes, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 9 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 31 Mar 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
Blood count test 1 (time frame: 6 weeks after baseline). The study lists 8 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 31 Mar 2022.