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Status unknownNCT05096078Updated Mar 31, 2022

The Effect of Circuit Exercise Program in Gestational Diabetes

An interventional study of Diet and Exercise in Gestational Diabetes, sponsored by Istanbul Medipol University Hospital. Status unknown at 1 site in Turkey. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Oct 2020, registered Oct 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Gestational Diabetes

Keywords

  • Gestational diabetes
  • Circuit Exercise
  • Cognition
03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's planned enrollment of 60 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

Istanbul Medipol University Hospital is the lead sponsor of 350 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Diet Group

    Individuals will receive only dietary treatment that the dietitian deems appropriate for 6 weeks.

    Other: Diet

  • Experimental
    Exercise Group

    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.

    Other: Diet · Other: Exercise

Interventions

  • OtherDiet

    Special diet program for gestational diabetes

  • OtherExercise

    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.

06

What researchers measure

Primary outcomes

  1. Blood count test 1

    Fasting blood glucose (FBG) value will be recorded.

    Time frame: 6 weeks after baseline

  2. Blood count test 2

    Postprandial blood glucose (PBG) value will be recorded.

    Time frame: 6 weeks after baseline

  3. Blood count test 3

    HbA1c value will be recorded.

    Time frame: 6 weeks after baseline

  4. Blood count test 4

    Total cholesterol (T-col) value will be recorded.

    Time frame: 6 weeks after baseline

  5. Blood count test 5

    High-density lipoprotein cholesterol (HDL) value will be recorded.

    Time frame: 6 weeks after baseline

  6. Blood count test 6

    Low-density lipoprotein cholesterol (LDL) value will be recorded.

    Time frame: 6 weeks after baseline

  7. Blood count test 7

    Insulin value will be recorded.

    Time frame: 6 weeks after baseline

  8. Blood count test 8

    Triglyceride (TG) value will be recorded.

    Time frame: 6 weeks after baseline

Secondary outcomes

  1. 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.

    Time frame: 6 weeks after baseline

  2. 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.

    Time frame: 6 weeks after baseline

07

Study locations

1 site
  • Istanbul Medipol University
    Istanbul, Beykoz 34815, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05096078
Lead sponsor
Istanbul Medipol University Hospital
Responsible party
Miray Budak (Principal Investigator, Istanbul Medipol University Hospital) — Principal investigator
First posted
Oct 27, 2021
Start date
Oct 16, 2020
Primary completion
Mar 2022 (estimated)
Completion
Jun 2022 (estimated)
Last update
Mar 31, 2022

Study contacts

Miray BUDAK, PhD
study director · Medipol University
Saadet Turhan
principal investigator · Medipol University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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