Optimization of Exercise Protocol for Prediabetic Population in Postprandial State

Not Applicable

Completed

• Conditions: Time; Prediabetes; Exercise; Blood Glucose Profile; Lipid Profile; Optimization

• Registration Number: NCT06656377
• Lead Sponsor: Khyber Medical University Peshawar

Brief Summary

The core purpose of the project is to find out optimal exercise protocol for control of hyperglycemia and insulin resistance in prediabetic. The results of the study will increase the current understandings of how exercise can be used in the most efficient manner to extract the maximum possible benefits and enhance adherence in best scientific manner possible.

Detailed Description

Participants will be selected from Peshawar and the study will be carried in accordance with the ethical code of research as per the revised (2013) declaration of Helsinki 1975. The volunteers will be recruited through posters, banners and personal contacts. The aims, objectives, purpose and procedure of the study will be explained to each participant. A written informed consent from all the participants will be taken after agreement and they will be informed about their right to leave the trial at any time if they don't want.

After selection, the recruited, participants will be asked to attend the lab for 12 visits over 6 months. On the day of experiment, patients will be received in Lab in fasting state, where baseline measurements, weight, age, BMI, W/H ratio, body composition will be determined. They will be screened for exercise fitness through PAR_Q and exercise readiness questionnaire. Detailed history of the patients (Diabetes Mellitus, medications, and economic conditions) and General Physical Examination will be carried out.

This study will be triphasic during which optimal timing of the exercise in post prandial state, optimal intensity of the exercise and optimal duration of the exercise will be quantified. For this a single cohort of 12 participants will be selected with crossover design who will attend the lab 12 times in total for all phases (04 visits for single phase). Each participant will attend the lab 12 times in total during the intervention. Each participant will be provided with one week time as wash out period.

The details of the actual visits of participants to Physiology Skill lab in detail is as under:

TIMING Protocol:

This protocol is aimed to determine the best possible time for exercise execution in postprandial state for prediabetics. During this protocol all the participants will visit the lab 04 times (7 days apart) in fasting and will be served with isocaloric breakfast (250 Kcal) after which the exercise will be started at different intervals with the following details:

Visit 1:

The participants will perform exercise 30 minutes after a standard isocaloric breakfast provided at the lab. Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) at moderate intensity (50% predicted maximum heart rate) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise for determination of blood glucose level, insulin, lipid profile and MicroRNAs (miR-192, miR193b).

Visit 2: - The participants will perform exercise 60 minutes after a standard isocaloric breakfast provided at the lab. Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) at moderate intensity (50% predicted maximum heart rate) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise for determination of blood glucose level, insulin, lipid profile and MicroRNAs (miR-192, miR193b).

Visit 3: - The participants will perform exercise 90 minutes after a standard isocaloric breakfast provided at the lab. Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) at moderate intensity (50% predicted maximum heart rate) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.

Visit4: - The participants will perform exercise 120 minutes after a standard isocaloric breakfast provided at the lab. Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) at moderate intensity (50% predicted maximum heart rate) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.

This protocol will provide us an optimal time for exercise in post prandial state.

Intensity Protocol:

This protocol is aimed to determine the best possible intensity of exercise in postprandial state for prediabetics. During this protocol all the participants will visit the lab 04 times (at least 2 days apart) in fasting and will be served with isocaloric breakfast (250 Kcal) after which the exercise will be started at the optimal time determined through previous protocol at different sub maximal intensities with the following details:

Visit 1:

The participants will perform exercise at 50% of predicted maximum heart rate (PMHR). Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.

Visit 2: - The participants will perform exercise at 60% of predicted maximum heart rate (PMHR). Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.

Visit 3: - The participants will perform exercise 70% of predicted maximum heart rate (PMHR). Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.

Visit4: - The participants will perform exercise 80% of predicted maximum heart rate (PMHR). Each exercise session will last for 40 minutes (05 minutes warm up, 05 minutes cool down) on treadmill. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise. However, this session might need fitness of the individuals and may be omitted for some participants based on their fitness level.

Duration Protocol:

This protocol is aimed to determine the best possible duration for exercise in postprandial state for prediabetics. During this protocol all the participants will visit the lab 04 times (at least 2 days apart) in fasting and will be served with isocaloric breakfast (250 Kcal) after which the exercise will be started at the optimal time and intensity determined through previous protocols for different durations with the following details:

Visit 1:

The participants will perform exercise at optimal timing and intensity determined previously for 15 minutes excluding warm up and cool down. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.

Visit 2: - The participants will perform exercise at optimal timing and intensity determined previously for 30 minutes excluding warm up and cool down. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.

Visit 3: - The participants will perform exercise at optimal timing and intensity determined previously for 45 minutes excluding warm up and cool down. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.

Visit4: - The participants will perform exercise at optimal timing and intensity determined previously for 60 minutes excluding warm up and cool down. Blood samples (05 ml approximately) will be taken at fasting, before exercise and 30 and 60 minutes after exercise.

However, this session might need fitness of the individuals and may be omitted for some participants based on their fitness level.

Analysis Procedure:

Sample analysis:

Blood glucose levels will be determined through glucometer and Insulin levels will be determined through sandwich Elisa. MicroRNAs will be extracted and then analyzed through real-time qPCR or microarray analysis.

Study Timeline

• Study Start: 2022-09-15
• Study First Submitted: 2024-10-14
• Primary Completion: 2024-10-20
• Study First Submitted QC: 2024-10-21
• Study First Posted: 2024-10-24
• Study Completion: 2024-11-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Prediabetic adults between 20-to-35-year age group with and without a family history of diabetes mellitus will be recruited into the study.
2. Diagnosis of prediabetes will be made through HbA1c (prediabetic range is 5·7 - 6·4%), and impaired fasting glucose (fasting plasma glucose 5·6 -6·9 mmol/L) -

Exclusion Criteria

1. Participants with type 2 diabetes and other diseases, on lipid-lowering drugs, pregnant and lactating females or participating in some other study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Exercise timings and Metabolic health: Targeting Blood glucose in Adults with Prediabetes post meal	8 months	This study aims to investigate the effects of varied exercise timing post-meal (30 min, 60 min, 90 min, and 120 minutes) on blood glucose levels. The Blood glucose levels will be measured at fasting, pre-exercise, 30 and 60 minutes post-exercise in mg/dL, using a standard glucose meter.
Exercise Timing and Metabolic health: Targeting Blood Insulin in Adults with Prediabetes post meal	8 months	his study aims to investigate the effects of varied exercise timing post-meal (30 min, 60 min, 90 min and 120 minutes) on Insulin levels. The Insulin levels will be measured at baseline, pre-exercise, 30 and 60 minutes post exercise, in the prediabetic population, to identify which intensity is the most effective time and improves these metabolic markers. Insulin levels will be measured using enzyme-linked immunosorbent assay (ElISA), reported in μU/mL.
Exercise timings and Metabolic health: Targeting C-peptide levels in Adults with Prediabetes post meal	8 months	This study aims to investigate the effects of varied exercise timing post-meal (30 minutes, 60 min, 90 min, and 120 minutes) on C-peptide levels. C-peptide levels will be assessed at fasting, pre-exercise, and 30 and 60 minutes post exercise using an enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL.
Exercise timings and Metabolic health: Targeting Lipid profile levels in Adults with Prediabetes post meal	8 months	This study aims to investigate the effects of varied exercise timing post-meal (30 minutes, 60 min, 90 min, and 120 minutes) on Lipid profile. The lipid profile, including total cholesterol, LDL, HDL, and triglycerides, will be measured in mg/dL. Measurements will be taken at baseline and at each post-exercise interval. The outcome will determine the exercise timing that leads to the most favorable lipid profile changes.
Exercise timings and Metabolic health: Targeting MiRNA 192 expression levels in Adults with Prediabetes post meal	8 months	This study aims to investigate the effects of varied exercise timing post-meal (30 minutes, 60 min, 90 min, and 120 minutes) on MiRNA-192. miRNA 192 expression levels will be measured using Real-time quantitative PCR (qPCR) techniques, with results presented as relative expression values. This outcome aims to identify which exercise timing most effectively influences miRNA 192 expression.
Exercise Intensities and Metabolic health: Targeting Blood glucose levels in Adults with Prediabetes post meal	8 months	This study aims to investigate the effects of varied exercise intensities (50%,60%,70%, and 80%) on previously optimized meal intake time and commencement of exercise on blood glucose levels in a prediabetic population, to identify which intensity is that most effective and improves these metabolic markers. Blood glucose levels will be measured at baseline and at each post-exercise interval (30, 60, 90, and 120 minutes) in mg/dL, using a standard glucose meter.
Exercise Intensities and Metabolic health: Targeting Insulin levels in Adults with Prediabetes post meal	8 months	This study aims to investigate the effects of varied exercise intensities (50%,60%,70%, and 80%) on previously optimized meal intake time and commencement of exercise on insulin levels in the prediabetic population, to identify which intensity is that most effective and improves these metabolic markers. Insulin levels will be measured at the same intervals using enzyme-linked immunosorbent assay Elisa, reported in μU/mL.
Exercise Intensities and Metabolic health: Targeting C-peptide levels in Adults with Prediabetes post meal	8 months	This study aims to investigate the effects of varied exercise intensities (50%,60%,70%, and 80%) on previously optimized meal intake time and commencement of exercise on C-peptide levels in the prediabetic population, to identify which intensity is the most effective and improves these metabolic markers. It will be measured at the same intervals using enzyme-linked immunosorbent assay Elisa, reported in ng/mL.
Exercise Intensities and Metabolic health: Targeting Lipid Profile in Adults with Prediabetes post meal	8 months	This study aims to investigate the effects of varied exercise intensities (50%,60%,70%, and 80%) on previously optimized meal intake time and commencement of exercise on Lipid profile. The lipid profile, including total cholesterol, LDL, HDL, and triglycerides, will be measured in mg/dL. Measurements will be taken at baseline and at each post-exercise interval. The outcome will determine the exercise timing that leads to the most favorable lipid profile changes.
Exercise Intensities and Metabolic health: Targeting MiRNA-192 in Adults with Prediabetes post meal	8 months	This study aims to investigate the effects of varied exercise intensities (50%,60%,70%, and 80%) on previously optimized meal intake time and commencement of exercise on MiRNA-192. miRNA 192 expression levels will be measured using quantitative PCR (qPCR) techniques, with results presented as relative expression values. This outcome aims to identify which exercise timing most effectively influences miRNA 192 expression.
Exercise duration and Metabolic health: Targeting Blood glucose levels in Adults with Prediabetes post meal	8 months	This study aims to investigate the effects of varied exercise duration of exercise (15, 30, 45, and 60 minutes workout) on previously optimized time and intensity on blood glucose levels. Blood glucose levels will be measured in mg/dL, using a standard glucose meter. The goal is to determine which exercise timing results in the most significant reduction in blood glucose levels.
Exercise duration and Metabolic health: Targeting Insulin levels in Adults with Prediabetes post meal	8 months	This study aims to investigate the effects of varied exercise duration of exercise (15, 30, 45, and 60 minutes workout) on previously optimized time and intensity on insulin levels in a prediabetic population, to identify whichduration is the most effective and improves this metabolic marker. insulin levels will be measured at the same intervals using a chemiluminescence immunoassay, reported in μU/mL. This outcome aims to identify the optimal timing for exercise in reducing insulin levels.
Exercise duration and Metabolic health: Targeting C-peptide in Adults with Prediabetes post meal	8 months	This study aims to investigate the effects of varied exercise duration of exercise (15, 30, 45, and 60 minutes workout) on previously optimized time and intensity on C-peptide levels in a prediabetic population, to identify which duration is the most effective and improves this metabolic marker. C-peptide levels will be assessed at each time point using an enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL. The analysis will focus on the timing of exercise that maximizes reductions in C-peptide levels.
Exercise duration and Metabolic health: Targeting Lipid Profile in Adults with Prediabetes post meal	8 months	This study aims to investigate the effects of varied exercise duration of exercise (15, 30, 45, and 60 minutes workout) on previously optimized time and intensity on Lipid Profile in a prediabetic population, to identify which duration is the most effective and improves thses metabolic marker. The lipid profile, including total cholesterol, LDL, HDL, and triglycerides, will be measured in mg/dL. Measurements will be taken at baseline and at each post-exercise interval. The outcome will determine the exercise timing that leads to the most favorable lipid profile changes.
Exercise duration and Metabolic health: Targeting MiRNA-192 in Adults with Prediabetes post meal	8 months	This study aims to investigate the effects of varied exercise duration of exercise (15, 30, 45, and 60 minutes workout) on previously optimized time and intensity on MiRNA-192 in a prediabetic population, to identify which Duration is the most effective and improves the marker. miRNA 192 expression levels will be measured using quantitative PCR (qPCR) techniques, with results presented as relative expression values. This outcome aims to identify which exercise timing most effectively influences miRNA 192 expression.

Trial Locations

Locations (1)

Khyber Medical University; 🇵🇰 Peshawar, Khyber Pukhtoon Khwa, Pakistan