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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05096078
Other study ID # GestationalDM.Exer.Cog.
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 16, 2020
Est. completion date June 2022

Study information

Verified date March 2022
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date June 2022
Est. primary completion date March 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - 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) Exclusion Criteria: - 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 - 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

Study Design


Intervention

Other:
Diet
Special diet program for gestational diabetes
Exercise
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.

Locations

Country Name City State
Turkey Istanbul Medipol University Istanbul Beykoz

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood count test 1 Fasting blood glucose (FBG) value will be recorded. 6 weeks after baseline
Primary Blood count test 2 Postprandial blood glucose (PBG) value will be recorded. 6 weeks after baseline
Primary Blood count test 3 HbA1c value will be recorded. 6 weeks after baseline
Primary Blood count test 4 Total cholesterol (T-col) value will be recorded. 6 weeks after baseline
Primary Blood count test 5 High-density lipoprotein cholesterol (HDL) value will be recorded. 6 weeks after baseline
Primary Blood count test 6 Low-density lipoprotein cholesterol (LDL) value will be recorded. 6 weeks after baseline
Primary Blood count test 7 Insulin value will be recorded. 6 weeks after baseline
Primary Blood count test 8 Triglyceride (TG) value will be recorded. 6 weeks after baseline
Secondary 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. 6 weeks after baseline
Secondary 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. 6 weeks after baseline
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