The Effect of Circuit Exercise Program in Gestational Diabetes

NCT05096078 | Unknown

• 1 other identifier: GestationalDM.Exer.Cog.
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gestational Diabetes

Keywords

Gestational diabetes; Circuit Exercise; Cognition

Outcome Measures

Primary Outcomes (8)

• Blood count test 1

  Fasting blood glucose (FBG) value will be recorded.

  6 weeks after baseline

• Blood count test 2

  Postprandial blood glucose (PBG) value will be recorded.

  6 weeks after baseline

• Blood count test 3

  HbA1c value will be recorded.

  6 weeks after baseline

• Blood count test 4

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

  6 weeks after baseline

• Blood count test 5

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

  6 weeks after baseline

• Blood count test 6

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

  6 weeks after baseline

• Blood count test 7

  Insulin value will be recorded.

  6 weeks after baseline

• Blood count test 8

  Triglyceride (TG) value will be recorded.

  6 weeks after baseline

Secondary Outcomes (2)

• Montreal Cognitive Assessment Scale

  6 weeks after baseline

• WMS Number Range Test

  6 weeks after baseline

Study Arms (2)

Diet Group

ACTIVE COMPARATOR

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

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.

Other: Diet; Other: Exercise

Interventions

Diet OTHER

Special diet program for gestational diabetes

Diet Group; Exercise Group

Exercise OTHER

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.

Exercise Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34815, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Miray BUDAK, PhD

  Medipol University

  STUDY DIRECTOR

• Saadet Turhan

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 27, 2021
• Study Start: October 16, 2020
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

TU (1)