Diabetes MellitusNCT03730168
Response of Inflammatory Markers to Circuit Weight Training in Diabetic Patients
A study testing circuit weight training program in people with Diabetes Mellitus, run by Cairo University at 1 site in Egypt.
Trial summary
Study group included 30 male diabetic patients , they performed circuit weight training exercises for 12 weeks in addition to their medications. However, the control group included 10 patients received medical treatment. Read more about this study
- Who is it for?
- Ages 45 to 55 years, men only
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- circuit weight training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 13 May 2018to 20 Aug 2018
- 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 45 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- The selected subjects are diagnosed clinically and laboratory with diabetes mellitus type 2 by physicians.
- All patients have moderate hyperglycemia tested by fasting plasma glucose and a two hours plasma glucose ≥ 200 mg/dl (11.1mmol/l) during an oral glucose tolerance test (OGTT).
- The onset of the disease will be more than 10 years.
- All patients follow an oral hypoglycemicdrug.
Who cannot join
- Hepatic diseases.
- Cancer patients.
- Renal failure patients.
- Orthopedic problems or fractures of extremities.
- Neurological problems.
- Severely hypertensive patients.
Trial locations and contacts
1 site in 1 country.
About this study
Study group included 30 male diabetic patients , they performed circuit weight training exercises for 12 weeks in addition to their medications. However, the control group included 10 patients received medical treatment.
Interleukin 6 and tumor necrosis factor alpha were measured before and after the study duration for both groups.
Read the detailed description
The study group included 30 male diabetic patients who participated in circuit weight training (CWT) program as following; 60 minutes training\day for 3 days per week for a period of 12 weeks.
The training session started by a proper warm up for 5-10 min in the form of mild stretching of the muscles of upper limb(pectorals,shoulder girdle muscles) and muscles of lower limb(flexors, extensors, abductors and adductors of the hip and knee) ( to minimize the risk of musculoskeletal injury). Then start the active phase of resisted exercises through using free weights ( dumbbels for upper limb and sand bags for lower limb) The frequency and intensity increased gradually as follows; Intensity of progress of CWT gradually increased intensity by 2.5% of one repetition maximum every two weeks. Moderate resistance used in which of 60-65% of 1RM in the first month then the intensity increased to 70-75% of 1RM in the second month and finally the intensity of exercises increased to 75-80% of 1RM during the third month. The sets of exercises intervened by 1 min rest in between each set of repetitions. At last the session ends by 10 min of cooling down in the form of relaxation exercises.
Statistical procedures:
In this study, the descriptive statistics (the mean, the standard deviation, maximum, minimum, and range) will be calculated for all subjects in the study including IL6 and tumor necrosis factor alpha variables.
- Paired sample t-test will be used to compare the difference between before and after treatment results of IL6 and tumor necrosis factor alpha in each group.
- Paired T test to compare means of variables before and after training.
- Conditions
- Diabetes Mellitus
- Being tested
- circuit weight training program
- Keywords
- Diabetes mellitus., Inflammatory markers, Circuit weight training
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
circuit weight training programOther
Also called Resisted exercises using free weights
30 male diabetic patients performed circuit weight training for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| study group and control group | Experimental | Two groups; study group included 30 diabetic male patients who where trained by circuit weight training program in the form of sets of resistance exercises (in the form of dumbbells and sand bags) for the muscles of lower limb and upper limb .The training sessions were performed 3 days per week for a period of 12 weeks. All patient were on their prescribed routine medications .
The control group were on there prescribed medications only . Receives: Other: circuit weight training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of serum intereukin6
Laboratory investigation to assess inflammatory marker response to circuit weight training program in male diabetic patients. training was three times weekly for 12 weeks.
Measured: change from baseline and after 12 weeks
Secondary outcomes (1)
concentration of serum tumour necrosis factor
Laboratory investigation to assess inflammatory marker response to circuit weight training program in male diabetic patients. training was three times weekly for 12 weeks.
Measured: change from baseine and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start13 May 2018
- Primary completion20 Aug 2018
- Study completion20 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Ahmed Ali Abdeen, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730168
- Sponsor's protocol ID
- p.t.rec/012/001570
- Status last verified
- Nov 2018
- First submitted
- 15 Oct 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response of Inflammatory Markers to Circuit Weight Training in Diabetic Patients
- ClinicalTrials.gov ID
- NCT03730168
- Acronym / sponsor ID
- p.t.rec/012/001570
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes mellitus., Inflammatory markers, Circuit weight training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 13 May 2018 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 5 Nov 2018 (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.
Study group included 30 male diabetic patients , they performed circuit weight training exercises for 12 weeks in addition to their medications. However, the control group included 10 patients received medical treatment.
Interleukin 6 and tumor necrosis factor alpha were measured before and after the study duration for both groups.
Detailed description
The study group included 30 male diabetic patients who participated in circuit weight training (CWT) program as following; 60 minutes training\day for 3 days per week for a period of 12 weeks.
The training session started by a proper warm up for 5-10 min in the form of mild stretching of the muscles of upper limb(pectorals,shoulder girdle muscles) and muscles of lower limb(flexors, extensors, abductors and adductors of the hip and knee) ( to minimize the risk of musculoskeletal injury). Then start the active phase of resisted exercises through using free weights ( dumbbels for upper limb and sand bags for lower limb) The frequency and intensity increased gradually as follows; Intensity of progress of CWT gradually increased intensity by 2.5% of one repetition maximum every two weeks. Moderate resistance used in which of 60-65% of 1RM in the first month then the intensity increased to 70-75% of 1RM in the second month and finally the intensity of exercises increased to 75-80% of 1RM during the third month. The sets of exercises intervened by 1 min rest in between each set of repetitions. At last the session ends by 10 min of cooling down in the form of relaxation exercises.
Statistical procedures:
In this study, the descriptive statistics (the mean, the standard deviation, maximum, minimum, and range) will be calculated for all subjects in the study including IL6 and tumor necrosis factor alpha variables.
- Paired sample t-test will be used to compare the difference between before and after treatment results of IL6 and tumor necrosis factor alpha in each group.
- Paired T test to compare means of variables before and after training.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group and control group | Experimental | Other: circuit weight training programTwo groups; study group included 30 diabetic male patients who where trained by circuit weight training program in the form of sets of resistance exercises (in the form of dumbbells and sand bags) for the muscles of lower limb and upper limb .The training sessions were performed 3 days per week for a period of 12 weeks. All patient were on their prescribed routine medications . The control group were on there prescribed medications only . |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The selected subjects are diagnosed clinically and laboratory with diabetes mellitus type 2 by physicians.
- All patients have moderate hyperglycemia tested by fasting plasma glucose and a two hours plasma glucose ≥ 200 mg/dl (11.1mmol/l) during an oral glucose tolerance test (OGTT).
- The onset of the disease will be more than 10 years.
- All patients follow an oral hypoglycemicdrug.
Key exclusion criteria (6 listed)
- Hepatic diseases.
- Cancer patients.
- Renal failure patients.
- Orthopedic problems or fractures of extremities.
- Neurological problems.
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 |
|---|---|---|
| circuit weight training programAlso: Resisted exercises using free weights30 male diabetic patients performed circuit weight training for 12 weeks | Other | study group and control group |
Primary outcome
concentration of serum intereukin6
Time frame: change from baseline and after 12 weeks
Laboratory investigation to assess inflammatory marker response to circuit weight training program in male diabetic patients. training was three times weekly for 12 weeks.
1 secondary outcome
concentration of serum tumour necrosis factor
Time frame: change from baseine and after 12 weeks
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 6 Nov 2018.
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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 circuit weight training program 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 4 inclusion and 6 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 6 Nov 2018. 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?
concentration of serum intereukin6 (time frame: change from baseline and after 12 weeks). 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 6 Nov 2018.