Type II Diabetes MellitusNCT04790526
Dose Response of Eccentric Exercise on Glycemic Control in Type II Diabetes Mellitus
A study testing Eccentric Exercises Dose in people with Type II Diabetes Mellitus, run by Riphah International University at 1 site in Pakistan.
Trial summary
The major aim of this project to check the dose response of eccentric exercise in reduction of glycemic index in type II Diabetes Mellitus. This study aim to check the effect of eccentric exercises on Glycemic index, quality of life, strength, exertion, balance and proprioception in type II Diabetes Mellitus patients Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- Eccentric Exercises Dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Jul 2021to 25 May 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cleared by a general practitioner to attend the training program Sedentary patients with controlled type 2 diabetes, according to the definition of the American Diabetes Association.
- Participants were untrained and had not engaged in resistance or aerobic exercise within 6 months prior to beginning the study.
- Age between 45-65 Years. BMI should be 18.5-34.9 kg/m2.
Who cannot join
- Participants with GIT disturbance (Gastroparesis and non-alcoholic fatty liver disease) will be excluded from the study.
- Participants with any kind of Musculo-skeletal injury will be excluded from the study.
- Participants with Stage II hypertension according to AHA guidelines. Participants who use tobacco products within the previous 6 months. Participants who take any type of systematic medication within the previous 6 months except diabetes.
- Participants with any symptoms of neuropathy, retinopathy or nephropathy will be excluded
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Rehabilitation Department, PSRD Hospital
Lahore, Punjab Province, 54000
About this study
Official title: Dose Response of Eccentric Exercises on Glycemic Control in Type ii Diabetes Mellitus
The major aim of this project to check the dose response of eccentric exercise in reduction of glycemic index in type II Diabetes Mellitus. This study aim to check the effect of eccentric exercises on Glycemic index, quality of life, strength, exertion, balance and proprioception in type II Diabetes Mellitus patients
Read the detailed description
From the last three decades, the diabetes mellitus progress quadrupled.The International Diabetes Federation (IDF) approximate that 1 in 11 adults with age between 20 to 79 years have diabetes mellitus. Almost 90 percent of patients diagnosed with Diabetes Mellitus are type 2 diabetes mellitus patients. According to the World Health Organization, Diabetes mellitus could be 7th leading cause of death. Type II Diabetes Mellitus (T2DM) increase progressively that affect around 25 million people in Europe and major public health issue for middle income countries. It is proposed that the prevalence of diabetes mellitus will increase up to 67% in middle-income countries from 2010 to 2030. In Pakistan, the Type II Diabetes Mellitus prevalence in 2018 is 11.77%. The prevalence is more in male as compared to females and urban area have 14.81 percent as compared to rural area.
The genetic architecture might partially determine an individual's response to environmental changes.The risk factors of Type II Diabetes Mellitus include obesity, ageing, behavioral and environment factors, diet and lifestyle. School-age children had also warned of a rise in childhood obesity in Pakistan, which is considered a strong risk factor in diabetic patients. The major cause of Type II Diabetes Mellitus is deficiency or loss of insulin. Brain utilize glucose as source of energy and when brain is unable to maintain integrity, Many physiological mechanism initiates to reduce and limit the effect of hypoglycemia.The response of human body in reaction to reduce glucose level causes lowering the secretion of insulin and release counter-regulatory hormone.Diabetes mellitus have strong correlation for reduction in muscular strength and functional status.
A recent study on global burden of diseases, Diabetes mellitus considered as ninth major cause of reduced life expectancy. A study conducted decades ago concluded that 3.96 million deaths occur due to diabetes mellitus with aged between 20-79 years. According to the International Diabetes Federation, the number and complications of diabetes mellitus increase rapidly up to 5.0 million deaths due to metabolic disorder.The prevalence of disability occurrence due to diabetes mellitus increase significantly since 3 decades ago. According to the global burden of Disease, Injuries and Risk factor statement, the 10th most common factor of disability was fasting level of glucose in 1990, 4th common cause till 2005 and 3rd common cause in 2015.45.8 percent of diabetes mellitus patients were approximately not diagnosed. Those patient who are not diagnosed have more risk of complication as compared to those who are diagnosed and start intervention. Medical expenditure of diabetes mellitus patients increases three times more than general population.The cases of people living suffering from Type II Diabetes Mellitus increase quadrupled between 1980 and 2014 globally. Adults who have diagnosed diabetes mellitus enhance to 20 percent from 2010 to 2030 and predicted to increase rapidly up to 69 percent. In Asia, the epidemic of Type II Diabetes Mellitus progress very rapidly and characterized by onset at a lower BMI and younger age than in Western populations. An average cost for the treatment of Diabetes Mellitus in Pakistan ranges from 650 to 20000 PKR.
- Conditions
- Type II Diabetes Mellitus
- Being tested
- Eccentric Exercises Dose
- Keywords
- Dose response, Eccentric exercise, Type II Diabetes Mellitus, Glycemic index
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric Exercises DoseOther
Eccentric exercise will be done treadmill in control environment. The treadmill will be declined to 16 degree and 3 sessions of 10 minutes duration will be given wit 1 minute of rest in each session. 10 minutes of warm up and cool down session will be given that includes stretching and stationary bicycle with out any resistance
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | This group includes 15 male participants who will be given 10 minutes of warm and cool down sessions that includes stationary bicycle without resistance and stretching. Intervention will be given with declination of treadmills at 16 degree and 3 session of 10 minutes duration will be given with 1 minutes of rest in each group. Intervention will be given for 3 sessions per week up to 12 weeks. Receives: Other: Eccentric Exercises Dose |
| Group B | Experimental | This group includes 15 female participants who will be given 10 minutes of warm and cool down sessions that includes stationary bicycle without resistance and stretching. Intervention will be given with declination of treadmills at 16 degree and 3 session of 10 minutes duration will be given with 1 minutes of rest in each group. Intervention will be given for 3 sessions per week up to 12 weeks. Receives: Other: Eccentric Exercises Dose |
| Group C | Experimental | This group includes 15 male participants who will be given 10 minutes of warm and cool down sessions that includes stationary bicycle without resistance and stretching. Intervention will be given with declination of treadmills at 16 degree and 3 session of 10 minutes duration will be given with 1 minutes of rest in each group. Intervention will be given for 5 sessions per week up to 12 weeks. Receives: Other: Eccentric Exercises Dose |
| Group D | Experimental | This group includes 15 female participants who will be given 10 minutes of warm and cool down sessions that includes stationary bicycle without resistance and stretching. Intervention will be given with declination of treadmills at 16 degree and 3 session of 10 minutes duration will be given with 1 minutes of rest in each group. Intervention will be given for 5 sessions per week up to 12 weeks. Receives: Other: Eccentric Exercises Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucometer
Glucometer will use to monitor glucose before and after the intervention. Glucometer have poor validity and reliability but consider medical tool for the management of diabetes.
Measured: 12 week
HBA1c
The A1C test is the most common diagnostic and screening tool used for Type II Diabetes Mellitus (T2DM) management and research
Measured: 0 week and 12th week
Secondary outcomes (6)
WHO-QOL (BREF-Urdu version)
WHOQOL-BREF is a short version of WHOQOL-100 developed under the supervision of World Health Organization.
Measured: 0 week,4th week,8th week and 12th week
Six Minutes' Walk Test
The Six-minute walk test (6-MWT) is also a widely used method for evaluating cardiopulmonary performance
Measured: 0 week,4th week,8th week and 12th week
Dynamometer
Commonly used devices that measure strength of body and include isometric lower limb muscle strength include dynamometers
Measured: 0 week,4th week,8th week and 12th week
Borg's Exertion Scale
Borg scale of exertion is widely used in patients to identify intensity of exercise
Measured: 0 week,4th week,8th week and 12th week
BERG Balance Scale
This scale is commonly used to check risk fall in elderly population
Measured: 0 week,4th week,8th week and 12th week
Joint error position test
Joint position error (JPE) is widely used to quantitatively assess proprioception in rehabilitation and sport science
Measured: 0 week,4th week,8th week and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start12 Jul 2021
- Primary completion30 Mar 2023
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Type II Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M Faheem Afzal, *PhD, Principal investigator, Lahore Medical and Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790526
- Sponsor's protocol ID
- RiphahIU M Faheem Afzal
- Status last verified
- Jul 2023
- First submitted
- 7 Mar 2021
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Magliano DJ, Boyko EJ; IDF Diabetes Atlas 10th edition scientific committee. IDF DIABETES ATLAS [Internet]. 10th edition. Brussels: International Diabetes Federation; 2021. Available from http://www.ncbi.nlm.nih.gov/books/NBK581934/
PubMed 35914061NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in diabetes since 1980: a pooled analysis of 751 population-based studies with 4.4 million participants. Lancet. 2016 Apr 9;387(10027):1513-1530. doi: 10.1016/S0140-6736(16)00618-8. Epub 2016 Apr 6.
PubMed 27061677Holman N, Young B, Gadsby R. Current prevalence of Type 1 and Type 2 diabetes in adults and children in the UK. Diabet Med. 2015 Sep;32(9):1119-20. doi: 10.1111/dme.12791. No abstract available.
PubMed 25962518Bruno G, Runzo C, Cavallo-Perin P, Merletti F, Rivetti M, Pinach S, Novelli G, Trovati M, Cerutti F, Pagano G; Piedmont Study Group for Diabetes Epidemiology. Incidence of type 1 and type 2 diabetes in adults aged 30-49 years: the population-based registry in the province of Turin, Italy. Diabetes Care. 2005 Nov;28(11):2613-9. doi: 10.2337/diacare.28.11.2613.
PubMed 16249528Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
PubMed 17132052The Federal Ministry of Health and Women, Division IV (2006) European Union conference on prevention of type 2 diabetes, Vienna.
Ogurtsova K, da Rocha Fernandes JD, Huang Y, Linnenkamp U, Guariguata L, Cho NH, Cavan D, Shaw JE, Makaroff LE. IDF Diabetes Atlas: Global estimates for the prevalence of diabetes for 2015 and 2040. Diabetes Res Clin Pract. 2017 Jun;128:40-50. doi: 10.1016/j.diabres.2017.03.024. Epub 2017 Mar 31.
PubMed 28437734Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4-14. doi: 10.1016/j.diabres.2009.10.007. Epub 2009 Nov 6.
PubMed 19896746Basit A, Fawwad A, Qureshi H, Shera AS; NDSP Members. Prevalence of diabetes, pre-diabetes and associated risk factors: second National Diabetes Survey of Pakistan (NDSP), 2016-2017. BMJ Open. 2018 Aug 5;8(8):e020961. doi: 10.1136/bmjopen-2017-020961.
PubMed 30082350Chatterjee S, Khunti K, Davies MJ. Type 2 diabetes. Lancet. 2017 Jun 3;389(10085):2239-2251. doi: 10.1016/S0140-6736(17)30058-2. Epub 2017 Feb 10.
PubMed 28190580O'Rahilly S. Human genetics illuminates the paths to metabolic disease. Nature. 2009 Nov 19;462(7271):307-14. doi: 10.1038/nature08532.
PubMed 19924209Sui X, Hooker SP, Lee IM, Church TS, Colabianchi N, Lee CD, Blair SN. A prospective study of cardiorespiratory fitness and risk of type 2 diabetes in women. Diabetes Care. 2008 Mar;31(3):550-5. doi: 10.2337/dc07-1870. Epub 2007 Dec 10.
PubMed 18070999Misra A, Vikram NK, Sharma R, Basit A. High prevalence of obesity and associated risk factors in urban children in India and Pakistan highlights immediate need to initiate primary prevention program for diabetes and coronary heart disease in schools. Diabetes Res Clin Pract. 2006 Jan;71(1):101-2. doi: 10.1016/j.diabres.2005.06.006. Epub 2005 Aug 19. No abstract available.
PubMed 16112243Chen L, Pei JH, Kuang J, Chen HM, Chen Z, Li ZW, Yang HZ. Effect of lifestyle intervention in patients with type 2 diabetes: a meta-analysis. Metabolism. 2015 Feb;64(2):338-47. doi: 10.1016/j.metabol.2014.10.018. Epub 2014 Oct 23.
PubMed 25467842Mitrakou A, Ryan C, Veneman T, Mokan M, Jenssen T, Kiss I, Durrant J, Cryer P, Gerich J. Hierarchy of glycemic thresholds for counterregulatory hormone secretion, symptoms, and cerebral dysfunction. Am J Physiol. 1991 Jan;260(1 Pt 1):E67-74. doi: 10.1152/ajpendo.1991.260.1.E67.
PubMed 1987794
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response of Eccentric Exercises on Glycemic Control in Type ii Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04790526
- Acronym / sponsor ID
- RiphahIU M Faheem Afzal
- Conditions
- Type II Diabetes Mellitus
- Keywords
- Dose response, Eccentric exercise, Type II Diabetes Mellitus, Glycemic index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 10 Mar 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.
The major aim of this project to check the dose response of eccentric exercise in reduction of glycemic index in type II Diabetes Mellitus. This study aim to check the effect of eccentric exercises on Glycemic index, quality of life, strength, exertion, balance and proprioception in type II Diabetes Mellitus patients
Detailed description
From the last three decades, the diabetes mellitus progress quadrupled.The International Diabetes Federation (IDF) approximate that 1 in 11 adults with age between 20 to 79 years have diabetes mellitus. Almost 90 percent of patients diagnosed with Diabetes Mellitus are type 2 diabetes mellitus patients. According to the World Health Organization, Diabetes mellitus could be 7th leading cause of death. Type II Diabetes Mellitus (T2DM) increase progressively that affect around 25 million people in Europe and major public health issue for middle income countries. It is proposed that the prevalence of diabetes mellitus will increase up to 67% in middle-income countries from 2010 to 2030. In Pakistan, the Type II Diabetes Mellitus prevalence in 2018 is 11.77%. The prevalence is more in male as compared to females and urban area have 14.81 percent as compared to rural area.
The genetic architecture might partially determine an individual's response to environmental changes.The risk factors of Type II Diabetes Mellitus include obesity, ageing, behavioral and environment factors, diet and lifestyle. School-age children had also warned of a rise in childhood obesity in Pakistan, which is considered a strong risk factor in diabetic patients. The major cause of Type II Diabetes Mellitus is deficiency or loss of insulin. Brain utilize glucose as source of energy and when brain is unable to maintain integrity, Many physiological mechanism initiates to reduce and limit the effect of hypoglycemia.The response of human body in reaction to reduce glucose level causes lowering the secretion of insulin and release counter-regulatory hormone.Diabetes mellitus have strong correlation for reduction in muscular strength and functional status.
A recent study on global burden of diseases, Diabetes mellitus considered as ninth major cause of reduced life expectancy. A study conducted decades ago concluded that 3.96 million deaths occur due to diabetes mellitus with aged between 20-79 years. According to the International Diabetes Federation, the number and complications of diabetes mellitus increase rapidly up to 5.0 million deaths due to metabolic disorder.The prevalence of disability occurrence due to diabetes mellitus increase significantly since 3 decades ago. According to the global burden of Disease, Injuries and Risk factor statement, the 10th most common factor of disability was fasting level of glucose in 1990, 4th common cause till 2005 and 3rd common cause in 2015.45.8 percent of diabetes mellitus patients were approximately not diagnosed. Those patient who are not diagnosed have more risk of complication as compared to those who are diagnosed and start intervention. Medical expenditure of diabetes mellitus patients increases three times more than general population.The cases of people living suffering from Type II Diabetes Mellitus increase quadrupled between 1980 and 2014 globally. Adults who have diagnosed diabetes mellitus enhance to 20 percent from 2010 to 2030 and predicted to increase rapidly up to 69 percent. In Asia, the epidemic of Type II Diabetes Mellitus progress very rapidly and characterized by onset at a lower BMI and younger age than in Western populations. An average cost for the treatment of Diabetes Mellitus in Pakistan ranges from 650 to 20000 PKR.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Eccentric Exercises DoseThis group includes 15 male participants who will be given 10 minutes of warm and cool down sessions that includes stationary bicycle without resistance and stretching. Intervention will be given with declination of treadmills at 16 degree and 3 session of 10 minutes duration will be given with 1 minutes of rest in each group. Intervention will be given for 3 sessions per week up to 12 weeks. |
| Group B | Experimental | Other: Eccentric Exercises DoseThis group includes 15 female participants who will be given 10 minutes of warm and cool down sessions that includes stationary bicycle without resistance and stretching. Intervention will be given with declination of treadmills at 16 degree and 3 session of 10 minutes duration will be given with 1 minutes of rest in each group. Intervention will be given for 3 sessions per week up to 12 weeks. |
| Group C | Experimental | Other: Eccentric Exercises DoseThis group includes 15 male participants who will be given 10 minutes of warm and cool down sessions that includes stationary bicycle without resistance and stretching. Intervention will be given with declination of treadmills at 16 degree and 3 session of 10 minutes duration will be given with 1 minutes of rest in each group. Intervention will be given for 5 sessions per week up to 12 weeks. |
| Group D | Experimental | Other: Eccentric Exercises DoseThis group includes 15 female participants who will be given 10 minutes of warm and cool down sessions that includes stationary bicycle without resistance and stretching. Intervention will be given with declination of treadmills at 16 degree and 3 session of 10 minutes duration will be given with 1 minutes of rest in each group. Intervention will be given for 5 sessions per week up to 12 weeks. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cleared by a general practitioner to attend the training program Sedentary patients with controlled type 2 diabetes, according to the definition of the American Diabetes Association.
- Participants were untrained and had not engaged in resistance or aerobic exercise within 6 months prior to beginning the study.
- Age between 45-65 Years. BMI should be 18.5-34.9 kg/m2.
Key exclusion criteria (4 listed)
- Participants with GIT disturbance (Gastroparesis and non-alcoholic fatty liver disease) will be excluded from the study.
- Participants with any kind of Musculo-skeletal injury will be excluded from the study.
- Participants with Stage II hypertension according to AHA guidelines. Participants who use tobacco products within the previous 6 months. Participants who take any type of systematic medication within the previous 6 months except diabetes.
- Participants with any symptoms of neuropathy, retinopathy or nephropathy will be excluded
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 |
|---|---|---|
| Eccentric Exercises DoseEccentric exercise will be done treadmill in control environment. The treadmill will be declined to 16 degree and 3 sessions of 10 minutes duration will be given wit 1 minute of rest in each session. 10 minutes of warm up and cool down session will be given that includes stretching and stationary bicycle with out any resistance | Other | Group A, Group B, Group C, Group D |
Primary outcome
Glucometer
Time frame: 12 week
Glucometer will use to monitor glucose before and after the intervention. Glucometer have poor validity and reliability but consider medical tool for the management of diabetes.
HBA1c
Time frame: 0 week and 12th week
The A1C test is the most common diagnostic and screening tool used for Type II Diabetes Mellitus (T2DM) management and research
6 secondary outcomes
WHO-QOL (BREF-Urdu version)
Time frame: 0 week,4th week,8th week and 12th week
Six Minutes' Walk Test
Time frame: 0 week,4th week,8th week and 12th week
Dynamometer
Time frame: 0 week,4th week,8th week and 12th week
Borg's Exertion Scale
Time frame: 0 week,4th week,8th week and 12th week
BERG Balance Scale
Time frame: 0 week,4th week,8th week and 12th week
Joint error position test
Time frame: 0 week,4th week,8th week and 12th week
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 10 Jul 2023.
- Background: PubMed 35914061Magliano DJ, Boyko EJ; IDF Diabetes Atlas 10th edition scientific committee. IDF DIABETES ATLAS [Internet]. 10th edition. Brussels: International Diabetes Federation; 2021. Available from http://www.ncbi.nlm.nih.gov/books/NBK581934/
- Background: PubMed 27061677NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in diabetes since 1980: a pooled analysis of 751 population-based studies with 4.4 million participants. Lancet. 2016 Apr 9;387(10027):1513-1530. doi: 10.1016/S0140-6736(16)00618-8. Epub 2016 Apr 6.
- Background: PubMed 25962518Holman N, Young B, Gadsby R. Current prevalence of Type 1 and Type 2 diabetes in adults and children in the UK. Diabet Med. 2015 Sep;32(9):1119-20. doi: 10.1111/dme.12791. No abstract available.
- Background: PubMed 16249528Bruno G, Runzo C, Cavallo-Perin P, Merletti F, Rivetti M, Pinach S, Novelli G, Trovati M, Cerutti F, Pagano G; Piedmont Study Group for Diabetes Epidemiology. Incidence of type 1 and type 2 diabetes in adults aged 30-49 years: the population-based registry in the province of Turin, Italy. Diabetes Care. 2005 Nov;28(11):2613-9. doi: 10.2337/diacare.28.11.2613.
- Background: PubMed 17132052Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
- BackgroundThe Federal Ministry of Health and Women, Division IV (2006) European Union conference on prevention of type 2 diabetes, Vienna.
- Background: PubMed 28437734Ogurtsova K, da Rocha Fernandes JD, Huang Y, Linnenkamp U, Guariguata L, Cho NH, Cavan D, Shaw JE, Makaroff LE. IDF Diabetes Atlas: Global estimates for the prevalence of diabetes for 2015 and 2040. Diabetes Res Clin Pract. 2017 Jun;128:40-50. doi: 10.1016/j.diabres.2017.03.024. Epub 2017 Mar 31.
- Background: PubMed 19896746Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4-14. doi: 10.1016/j.diabres.2009.10.007. Epub 2009 Nov 6.
- Background: PubMed 30082350Basit A, Fawwad A, Qureshi H, Shera AS; NDSP Members. Prevalence of diabetes, pre-diabetes and associated risk factors: second National Diabetes Survey of Pakistan (NDSP), 2016-2017. BMJ Open. 2018 Aug 5;8(8):e020961. doi: 10.1136/bmjopen-2017-020961.
- Background: PubMed 28190580Chatterjee S, Khunti K, Davies MJ. Type 2 diabetes. Lancet. 2017 Jun 3;389(10085):2239-2251. doi: 10.1016/S0140-6736(17)30058-2. Epub 2017 Feb 10.
- Background: PubMed 19924209O'Rahilly S. Human genetics illuminates the paths to metabolic disease. Nature. 2009 Nov 19;462(7271):307-14. doi: 10.1038/nature08532.
- Background: PubMed 18070999Sui X, Hooker SP, Lee IM, Church TS, Colabianchi N, Lee CD, Blair SN. A prospective study of cardiorespiratory fitness and risk of type 2 diabetes in women. Diabetes Care. 2008 Mar;31(3):550-5. doi: 10.2337/dc07-1870. Epub 2007 Dec 10.
- Individual participant dataSharing planned: No
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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.
M Faheem Afzal, *PhD principal investigator
Lahore Medical and Dental College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric Exercises Dose in people with Type II Diabetes Mellitus, run by Riphah International University at 1 site in Pakistan.
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 4 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 10 Jul 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 Pakistan. 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?
Glucometer (time frame: 12 week). The study lists 2 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 NCT04790526, which also lists 26 linked publications.
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 10 Jul 2023.