Diabetes MellitusNCT05110404
COMPARISON BETWEEN TWO SUB-TYPES OF HIGH INTENSITY INTERVAL TRAINING
A study testing The high-volume HIIT and The low-volume HIIT in people with Diabetes Mellitus, run by Cairo University at 1 site in Egypt.
Trial summary
Recently, HIIT has been recommended by the American diabetes association for type 2 diabetes. The high-volume HIIT has been studied extensively in patients with type 2 diabetes, however, little is known about the effectiveness of low-volume HIIT regarding target glycemic or lipid control in these patients. Read more about this study
- Who is it for?
- Ages 35 to 45 years, women only
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- The high-volume HIIT and The low-volume HIIT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Dec 2021to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Type II diabetes mellitus diagnosed by a physician as having HbA 1c of \> 6.5%.
- An established diagnosis of T2DM for at least 1year and less than 5 years.
- Women patients.
- Age between 35 to 45 years old.
- Systolic Blood pressure less than or equal 130 mmHg.
- Obese patients (BMI is between 30 and 39.9 kg/m 2 )
Show all 10Show fewer
- Patients with HbA 1c of 7-9%.
- A self-reported sedentary lifestyle.
- Patients receiving oral hypoglycemic medications described by the physician
- Patients with hyperlipidemia.
Who cannot join
- Patients with Cardiac diseases.
- Patients with glaucoma.
- Patients with diabetic complications (Diabetic foot, retinopathy, nephropathy, and diabetic peripheral neuropathy).
- Musculoskeletal or neurological limitations to physical exercise.
- Pregnancy
- Patients under insulin therapy
Show all 12Show fewer
- Patients with poorly controlled DM (HbA1c \> 9%)
- Bronchial asthma and chronic obstructive pulmonary disease.
- Smokers.
- Morbidly obese BMI ≥ 40 kg/m 2
- Males.
- 11. Systolic Blood pressure more than 130 mmHg. 12. Anemia ( hemoglobin \< 12 g/dL) 13. Osteopenia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECT OF HIGH VERSUS LOW-VOLUME HIGH INTENSITY INTERVAL TRAINING ON GLYCEMIC AND LIPIDS CONTROL IN TYPE 2 DIABETES
Recently, HIIT has been recommended by the American diabetes association for type 2 diabetes. The high-volume HIIT has been studied extensively in patients with type 2 diabetes, however, little is known about the effectiveness of low-volume HIIT regarding target glycemic or lipid control in these patients. Therefore, the purpose of this study is to compare between two subtypes of HIIT (i.e. the low-volume HIIT versus the high-volume HIIT) with respect to exercise-induced changes in blood glucose, lipid profile and anthropometry in patients with type 2 diabetes mellitus. Statement of the Problem Is there any difference between the effect of high-volume and the low-volume high intensity interval training on glycemic and lipids control in type 2 diabetes?
Purpose of the study:
Read more
To assess the effect of the high-volume versus the low-volume high intensity interval training on glycemic and blood lipids control in type 2 diabetes.
Null Hypothesis:
There will be no difference between the effect of the high-volume versus the low-volume high intensity interval training on glycemic and blood lipids control in type 2 diabetes.
- Conditions
- Diabetes Mellitus
- Being tested
- The high-volume HIIT, The low-volume HIIT
- Keywords
- DM
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The high-volume HIITOther
patients will undergo a warm up at 65%-70% of HRpeak for 5 minutes, and then they will walk on a treadmill for 4 intervals of 4 min each at an intensity corresponding to 85%-90% of HRpeak with 3 min active recovery interval interval in between at 65%-75% of HRpeak. Finally, a 3-min cool-down period will be permitted. The speed and the inclination of the treadmill will be adjusted between intervals to ensure that all patients are exercising at the desired target heart rate monitored by Pulse Oximeter.
The low-volume HIITOther
Each session will start with a 5-minute warm up at 65-70% of peak HR. Then they will walk on a treadmill for 4 intervals of 2 min each at an intensity corresponding to 85%-90% of HRpeak with three intervals of active recovery in between for 2 min at 65%-75% of HRpeak. Finally, a 3-min cool-down period will be permitted.
| Study group | Role | What they receive |
|---|---|---|
| Group (A): The high-volume HIIT | Active comparator | Exercise group A (n=30): It will include patients that will perform high-volume high-intensity interval training (HIIT), and will receive medical intervention. Receives: Other: The high-volume HIIT |
| Group (B): The low-volume HIIT | Active comparator | Exercise group B (n=30): will receive medical intervention. that will perform the low-volume high-intensity interval training, and will receive medical intervention. Receives: Other: The low-volume HIIT |
| Group C | No intervention | patients will receive medical intervention only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
body mass index
change in body mass index
Measured: 12 weeks
waist circumference
change in waist circumference
Measured: 12 weeks
waist/hip ratio
change in waist/hip ratio
Measured: 12 weeks
Systolic and diastolic blood pressure
change in Systolic and diastolic blood pressure
Measured: 12 weeks
HbA1c
change in HbA1c
Measured: 12 weeks
fasting & 2-h post prandial blood glucose
change in fasting \& 2-h post prandial blood glucose
Measured: 12 weeks
fasting lipid profile
change in fasting lipid profile
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start25 Dec 2021
- Primary completion30 Apr 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mohamed Mahmoud Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110404
- Sponsor's protocol ID
- P.T.REC/012/002900
- Status last verified
- Feb 2023
- First submitted
- 21 Oct 2021
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ahmad AM, Mahmoud AM, Serry ZH, Mohamed MM, Abd Elghaffar HA. Effects of low-versus high-volume high-intensity interval training on glycemic control and quality of life in obese women with type 2 diabetes. A randomized controlled trial. J Exerc Sci Fit. 2023 Oct;21(4):395-404. doi: 10.1016/j.jesf.2023.08.003. Epub 2023 Aug 30.
PubMed 37954548
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF HIGH VERSUS LOW-VOLUME HIGH INTENSITY INTERVAL TRAINING ON GLYCEMIC AND LIPIDS CONTROL IN TYPE 2 DIABETES
- ClinicalTrials.gov ID
- NCT05110404
- Acronym / sponsor ID
- P.T.REC/012/002900
- Conditions
- Diabetes Mellitus
- Keywords
- DM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Dec 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recently, HIIT has been recommended by the American diabetes association for type 2 diabetes. The high-volume HIIT has been studied extensively in patients with type 2 diabetes, however, little is known about the effectiveness of low-volume HIIT regarding target glycemic or lipid control in these patients. Therefore, the purpose of this study is to compare between two subtypes of HIIT (i.e. the low-volume HIIT versus the high-volume HIIT) with respect to exercise-induced changes in blood glucose, lipid profile and anthropometry in patients with type 2 diabetes mellitus. Statement of the Problem Is there any difference between the effect of high-volume and the low-volume high intensity interval training on glycemic and lipids control in type 2 diabetes?
Purpose of the study:
To assess the effect of the high-volume versus the low-volume high intensity interval training on glycemic and blood lipids control in type 2 diabetes.
Null Hypothesis:
There will be no difference between the effect of the high-volume versus the low-volume high intensity interval training on glycemic and blood lipids control in type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (A): The high-volume HIIT | Active comparator | Other: The high-volume HIITExercise group A (n=30): It will include patients that will perform high-volume high-intensity interval training (HIIT), and will receive medical intervention. |
| Group (B): The low-volume HIIT | Active comparator | Other: The low-volume HIITExercise group B (n=30): will receive medical intervention. that will perform the low-volume high-intensity interval training, and will receive medical intervention. |
| Group C | No intervention | –patients will receive medical intervention only. |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Type II diabetes mellitus diagnosed by a physician as having HbA 1c of \> 6.5%.
- An established diagnosis of T2DM for at least 1year and less than 5 years.
- Women patients.
- Age between 35 to 45 years old.
- Systolic Blood pressure less than or equal 130 mmHg.
Key exclusion criteria (12 listed)
- Patients with Cardiac diseases.
- Patients with glaucoma.
- Patients with diabetic complications (Diabetic foot, retinopathy, nephropathy, and diabetic peripheral neuropathy).
- Musculoskeletal or neurological limitations to physical exercise.
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The high-volume HIITpatients will undergo a warm up at 65%-70% of HRpeak for 5 minutes, and then they will walk on a treadmill for 4 intervals of 4 min each at an intensity corresponding to 85%-90% of HRpeak with 3 min active recovery interval interval in between at 65%-75% of HRpeak. Finally, a 3-min cool-down period will be permitted. The speed and the inclination of the treadmill will be adjusted between intervals to ensure that all patients are exercising at the desired target heart rate monitored by Pulse Oximeter. | Other | Group (A): The high-volume HIIT |
| The low-volume HIITEach session will start with a 5-minute warm up at 65-70% of peak HR. Then they will walk on a treadmill for 4 intervals of 2 min each at an intensity corresponding to 85%-90% of HRpeak with three intervals of active recovery in between for 2 min at 65%-75% of HRpeak. Finally, a 3-min cool-down period will be permitted. | Other | Group (B): The low-volume HIIT |
Primary outcome
body mass index
Time frame: 12 weeks
change in body mass index
waist circumference
Time frame: 12 weeks
change in waist circumference
waist/hip ratio
Time frame: 12 weeks
change in waist/hip ratio
Systolic and diastolic blood pressure
Time frame: 12 weeks
change in Systolic and diastolic blood pressure
HbA1c
Time frame: 12 weeks
change in HbA1c
fasting & 2-h post prandial blood glucose
Time frame: 12 weeks
change in fasting \& 2-h post prandial blood glucose
fasting lipid profile
Time frame: 12 weeks
change in fasting lipid profile
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Derived from this study: PubMed 37954548Ahmad AM, Mahmoud AM, Serry ZH, Mohamed MM, Abd Elghaffar HA. Effects of low-versus high-volume high-intensity interval training on glycemic control and quality of life in obese women with type 2 diabetes. A randomized controlled trial. J Exerc Sci Fit. 2023 Oct;21(4):395-404. doi: 10.1016/j.jesf.2023.08.003. Epub 2023 Aug 30.
Related trials for Diabetes Mellitus
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
Active, not recruitingPhase 3
Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
Lipodystrophy, Diabetes
Active, not recruitingPhase 2
Islet Cell Transplant for Type 1 Diabetes
Type 1 Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The high-volume HIIT and The low-volume HIIT in people with Diabetes Mellitus, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body mass index (time frame: 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05110404, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.