Clinical trial NCT06656377: Optimization of Exercise Protocol for Prediabetic Population in Postprandial State
Official title: Optimization of Exercise Protocol for Prediabetic Population in Postprandial State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Exercise
Blood Glucose Profile
Lipid Profile
Optimization
Time
Keywords: prediabetes
Exercise
Optimization
Time
Intensity
Duration
Lead sponsor: Khyber Medical University Peshawar
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: In this interventional study, we will include prediabetic patients who will undergo three sequential exercise protocols to optimize exercise timing, intensity, and duration. Each protocol is designed to explore a unique combination of these exercise parameters, allowing us to assess the effects on health outcomes relevant to prediabetes management. By using a randomized, cross-over design, participants will experience different exercise regimens, enabling us to compare the impact of each combination on glucose control, cardiovascular health, and overall metabolic function. This study aims to develop evidence-based exercise guidelines specifically tailored to prediabetic individuals.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Exercise timings and Metabolic health: Targeting Blood glucose in Adults with Prediabetes post meal
timeFrame: 8 months
measure: Exercise Timing and Metabolic health: Targeting Blood Insulin in Adults with Prediabetes post meal
timeFrame: 8 months
measure: Exercise timings and Metabolic health: Targeting C-peptide levels in Adults with Prediabetes post meal
timeFrame: 8 months
measure: Exercise timings and Metabolic health: Targeting Lipid profile levels in Adults with Prediabetes post meal
timeFrame: 8 months
measure: Exercise timings and Metabolic health: Targeting MiRNA 192 expression levels in Adults with Prediabetes post meal
timeFrame: 8 months
measure: Exercise Intensities and Metabolic health: Targeting Blood glucose levels in Adults with Prediabetes post meal
timeFrame: 8 months
measure: Exercise Intensities and Metabolic health: Targeting Insulin levels in Adults with Prediabetes post meal
timeFrame: 8 months
measure: Exercise Intensities and Metabolic health: Targeting C-peptide levels in Adults with Prediabetes post meal
timeFrame: 8 months
measure: Exercise Intensities and Metabolic health: Targeting Lipid Profile in Adults with Prediabetes post meal
timeFrame: 8 months
measure: Exercise Intensities and Metabolic health: Targeting MiRNA-192 in Adults with Prediabetes post meal
timeFrame: 8 months
measure: Exercise duration and Metabolic health: Targeting Blood glucose levels in Adults with Prediabetes post meal
timeFrame: 8 months
measure: Exercise duration and Metabolic health: Targeting Insulin levels in Adults with Prediabetes post meal
timeFrame: 8 months
measure: Exercise duration and Metabolic health: Targeting C-peptide in Adults with Prediabetes post meal
timeFrame: 8 months
measure: Exercise duration and Metabolic health: Targeting Lipid Profile in Adults with Prediabetes post meal
timeFrame: 8 months
measure: Exercise duration and Metabolic health: Targeting MiRNA-192 in Adults with Prediabetes post meal
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Khyber Medical University
state: Khyber Pukhtoon Khwa
Study officials:
affiliation: Khyber Medical University Peshawar, Pakistan
name: Saman Tauqir, Mphil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rynders CA, Weltman JY, Jiang B, Breton M, Patrie J, Barrett EJ, Weltman A. Effects of exercise intensity on postprandial improvement in glucose disposal and insulin sensitivity in prediabetic adults. J Clin Endocrinol Metab. 2014 Jan;99(1):220-8. doi: 10.1210/jc.2013-2687. Epub 2013 Dec 20.
citation: Marliss EB, Vranic M. Intense exercise has unique effects on both insulin release and its roles in glucoregulation: implications for diabetes. Diabetes. 2002 Feb;51 Suppl 1:S271-83. doi: 10.2337/diabetes.51.2007.s271.
citation: Manders RJ, Van Dijk JW, van Loon LJ. Low-intensity exercise reduces the prevalence of hyperglycemia in type 2 diabetes. Med Sci Sports Exerc. 2010 Feb;42(2):219-25. doi: 10.1249/MSS.0b013e3181b3b16d.
citation: Irving BA, Davis CK, Brock DW, Weltman JY, Swift D, Barrett EJ, Gaesser GA, Weltman A. Effect of exercise training intensity on abdominal visceral fat and body composition. Med Sci Sports Exerc. 2008 Nov;40(11):1863-72. doi: 10.1249/MSS.0b013e3181801d40.