Effects of Exercise and Metformin on Methylglyoxal Levels in Prediabetic Individuals

NCT06603480 | Completed

• 1 other identifier: MEGS
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effects of exercise, standard lifestyle changes and metformin on MGO in prediabetic individuals.

Conditions

Methylglyoxal; PreDiabetes; Exercise; Metformin

Keywords

Physical activity; PreDiabetes; Metformin; Methylglyoxal

Outcome Measures

Primary Outcomes (1)

• MGO

  Methylgloxal level

  1 week

Study Arms (3)

Aerobic Exercise

ACTIVE COMPARATOR

12 week aerobic exercise

Behavioral: Exercise

Metformin

EXPERIMENTAL

Metformin 2\*1 given

Other: Metformin

Control

NO INTERVENTION

Only routine

Interventions

Exercise BEHAVIORAL

Aerobic exercise (moderate intensity) at 50-70% of maximum heart rate for 60 minutes, 3 days a week for 12 weeks

Aerobic Exercise

Metformin OTHER

Patients who started Metformin 2\*1

Metformin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who were newly diagnosed with prediabetes by Oral Glucose Tolerance Test (OGTT) and/or HbA1C,
• who were assessed as physically inactive (Level 1) according to the International Physical Activity Questionnaire
• who had sufficient motivation to participate in the exercise program (assessed by one-on-one interviews conducted by the researchers),
• who were deemed suitable to participate in the exercise program after a cardiac examination by a cardiologist (with resting electrocardiogram and questioning of cardiac symptoms, and advanced tests such as exercise electrocardiogram test when necessary),
• who had the same weight (±2.5 kg) for 6 months before participating in the study.

You may not qualify if:

• having a serious medical condition that would prevent the person from participating in the exercise study (e.g. advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.),
• having used metformin for 6 months before the study, having cardiovascular disease,
• heart failure, cancer, having a BMI \<19 kg/m2, receiving hormone replacement therapy,
• having a life expectancy of less than 1 year, being HIV positive, substance use,
• functional dependence, having an orthopedic disease that prevents physical activity,
• having cognitive impairment and other diseases that would affect the study results (respiratory diseases, muscle diseases, non-alcoholic fatty liver disease, etc.),
• using medications or supplements that would affect the study results.

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Sultan 2. Abdülhamid Han Training and Research Hospital

Üsküdar, Istanbul, 34660, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prediabetic State; Motor Activity

Interventions

Exercise; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: April 8, 2021
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

TU (1)