High Intensity Interval TrainingNCT04830995
Insulin Sensitivity Response to High-Intensity Training in Insulin Resistance During Pregnancy
A study testing moderate restricted diet (1800-2000 kcal/day) for four weeks in people with High Intensity Interval Training and Diet, Healthy, run by Cairo University at 1 site in Egypt.
Trial summary
Insulin Resistance is one of the common complications that occur during pregnancy. Early intervention is essential to prevent the development of the diseaseThere is evidence that physical inactivity increases the risk of a lot of adverse health problems, including coronary heart disease, type 2 diabetes, breast and… Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- High Intensity Interval Training, Diet, Healthy
- What is being tested?
- moderate restricted diet (1800-2000 kcal/day) for four weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Mar 2020to 1 Nov 2020
- 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- forty multigravida females.
- their age ranged between 25 to 35 years old.
- Body mass index (BMI) <30kg/ m².
Who cannot join
- females with pelvic pathology as endometriosis.
- females have irregular menstrual cycles.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of High-Intensity Interval Training on Insulin Resistance During Pregnancy: A Randomized Control Trial.
Insulin Resistance is one of the common complications that occur during pregnancy. Early intervention is essential to prevent the development of the diseaseThere is evidence that physical inactivity increases the risk of a lot of adverse health problems, including coronary heart disease, type 2 diabetes, breast and colon cancers. It also shortens life expectancy. Pregnancy is a period in the life of women that is often associated with decreased daily physical activity and decreased participation in sports and exercise . In the first few weeks of pregnancy, maternal carbohydrate metabolism is affected by a rise in maternal levels of estrogen and progesterone that stimulates pancreatic β-cell hyperplasia and insulin secretion. As pregnancy progress, pancreatic islet cell hypertrophy continues and there is an increased insulin response to glucose or meal stimulation.
Read the detailed description
This study was carried out upon twenty multigravida pregnant female between 5-6 months gestation with IR calculated by HOMA test (fasting blood glucose× fasting insulin) ÷ 22.5. Fasting blood glucose was assessed by the method approved by (7, 13) .The test materials for this method were supplied as kits by "Diamond Diagnostics," while Insulin concentrations were stated in formerly frozen and defrosted serum samples by enzyme immunoassay using the human Insulin ELISA kits.
- Conditions
- High Intensity Interval Training, Diet, Healthy
- Being tested
- moderate restricted diet (1800-2000 kcal/day) for four weeks
- Keywords
- Training, Insulin Resistance, Pregnancy
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moderate restricted diet (1800-2000 kcal/day) for four weeksDietary supplement
Also called high intensity interval training
high intensity interval training 3 sessions for four weeks
| Study group | Role | What they receive |
|---|---|---|
| diet program | Experimental | moderate restricted diet (1800-2000 kcal/day) for four weeks, 3 sessions weekly Receives: Dietary Supplement: moderate restricted diet (1800-2000 kcal/day) for four weeks |
| high intensity interval training | Experimental | high intensity interval training for four weeks, 3 sessions weekly Receives: Dietary Supplement: moderate restricted diet (1800-2000 kcal/day) for four weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood glucose level
Fasting blood glucose level were measured by expert specialist before and after intervention period from 24th to 37th weeks of pregnancy.
Measured: three months
Secondary outcomes (1)
Fasting Insulin Level
Fasting blood insulin level were measured by expert specialist before and after intervention period from 24th to 37th weeks of pregnancy.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start24 Mar 2020
- Primary completion30 Oct 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Intensity Interval TrainingStudies 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
- Model description
- group (A) received HIIT and low diet for four weeks, 3 sessions weekly. While the control group received diet only.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Heba mohamed Embaby, Salwa Elgendy
- Responsible party
- Principal investigator, Ghada Ebrahim El Refaye, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830995
- Sponsor's protocol ID
- Cairo Un100
- Status last verified
- Jan 2023
- First submitted
- 1 Apr 2021
- Last updated
- 19 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of High-Intensity Interval Training on Insulin Resistance During Pregnancy: A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT04830995
- Acronym / sponsor ID
- Cairo Un100
- Conditions
- High Intensity Interval Training, Diet, Healthy
- Keywords
- Training, Insulin Resistance, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Heba mohamed Embaby, Salwa Elgendy
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 5 Apr 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.
Insulin Resistance is one of the common complications that occur during pregnancy. Early intervention is essential to prevent the development of the diseaseThere is evidence that physical inactivity increases the risk of a lot of adverse health problems, including coronary heart disease, type 2 diabetes, breast and colon cancers. It also shortens life expectancy. Pregnancy is a period in the life of women that is often associated with decreased daily physical activity and decreased participation in sports and exercise . In the first few weeks of pregnancy, maternal carbohydrate metabolism is affected by a rise in maternal levels of estrogen and progesterone that stimulates pancreatic β-cell hyperplasia and insulin secretion. As pregnancy progress, pancreatic islet cell hypertrophy continues and there is an increased insulin response to glucose or meal stimulation.
Detailed description
This study was carried out upon twenty multigravida pregnant female between 5-6 months gestation with IR calculated by HOMA test (fasting blood glucose× fasting insulin) ÷ 22.5. Fasting blood glucose was assessed by the method approved by (7, 13) .The test materials for this method were supplied as kits by "Diamond Diagnostics," while Insulin concentrations were stated in formerly frozen and defrosted serum samples by enzyme immunoassay using the human Insulin ELISA kits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- group (A) received HIIT and low diet for four weeks, 3 sessions weekly. While the control group received diet only.
| Arm | Type | Receives |
|---|---|---|
| diet program | Experimental | Dietary Supplement: moderate restricted diet (1800-2000 kcal/day) for four weeksmoderate restricted diet (1800-2000 kcal/day) for four weeks, 3 sessions weekly |
| high intensity interval training | Experimental | Dietary Supplement: moderate restricted diet (1800-2000 kcal/day) for four weekshigh intensity interval training for four weeks, 3 sessions weekly |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- forty multigravida females.
- their age ranged between 25 to 35 years old.
- Body mass index (BMI) <30kg/ m².
Key exclusion criteria (2 listed)
- females with pelvic pathology as endometriosis.
- females have irregular menstrual cycles.
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 |
|---|---|---|
| moderate restricted diet (1800-2000 kcal/day) for four weeksAlso: high intensity interval traininghigh intensity interval training 3 sessions for four weeks | Dietary supplement | diet program, high intensity interval training |
Primary outcome
Fasting blood glucose level
Time frame: three months
Fasting blood glucose level were measured by expert specialist before and after intervention period from 24th to 37th weeks of pregnancy.
1 secondary outcome
Fasting Insulin Level
Time frame: three months
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 19 Jan 2023.
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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 moderate restricted diet (1800-2000 kcal/day) for four weeks in people with High Intensity Interval Training and Diet, Healthy, 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 3 inclusion and 2 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 19 Jan 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?
Fasting blood glucose level (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2023.