Type 1 Diabetes MellitusPICTURENCT03069196
Prevalence and Incidence of Complications of Type One Diabetes in PUne At a Tertiary Care CentRE
An observational study of Type 1 Diabetes Mellitus, run by Kem Hospital, Pune, India at 1 site in India.
Trial summary
Due to early diagnosis (<20yrs of age) of Type 1 Diabetes, patients face longer duration of disease and greater glycemic exposure which makes them more vulnerable towards chronic complications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 323 participants
- Where
- 1 siteIndia
- Study dates
- 10 Jun 2016to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population includes those people who have been clinically diagnosed with Type 1 Diabetes. These participants will be selected from those enrolled at Diabetes Unit, KEMHRC, Pune, India.
Who may be able to join
- Type 1 Diabetes with a duration of diabetes more than 1 year.
- Willingness to participate in the study and sign the consent form.
- Age : all age groups
- Gender : Both
Who cannot join
- Other forms of diabetes like Type 2 Diabetes, Gestational Diabetes, Fibro Calculus Pancreatic Disease (FCPD), Mature Onset of Diabetes in Young (MODY) etc.
- People with acute stages of diseases like pneumonia after being treated for the condition.
- Advanced end stage conditions like Cancer etc.
- Pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
India1 site
Diabetes Unit, Kem Hospital Research Centre
Pune, Maharashtra, 411014
About this study
Official title: A Study to Assess Prevalence and Incidence of Long-term Complications of Type 1 Diabetes in a Tertiary Clinic in Pune.
Due to early diagnosis (<20yrs of age) of Type 1 Diabetes, patients face longer duration of disease and greater glycemic exposure which makes them more vulnerable towards chronic complications. The aim of this study is to investigate the prevalence and incidence of micro and macro-vascular, pulmonary complications and patterns of growth failure in approximately 500 Type 1 Diabetes patients enrolled at Diabetes Unit, King Edward Memorial Hospital Research Centre. Then follow up of 100 participants who are above 15 years of age at baseline will be done after 2 years to document incidence and progression of complications. This will contribute in assessing the public health burden of complications of Type 1 Diabetes.
Factors associated with prevalence of complications will be investigated. This risk factor analysis could aid in further modifying current prevention and treatment recommendations of these complications. Results of this study could modify current clinical practice.
Read the detailed description
BACKGROUND \& RATIONALE OF THE STUDY:
Type 1 Diabetes (T1D) is characterized by progressive destruction of insulin secreting pancreatic β-cells. The commonest mechanism involves autoimmunity to components of β-cells. As per International Diabetes Federation report 2013, India houses 67,700 children (<15yrs) with T1D. It also states an approximate figure of 10,900 newly diagnosed T1D children (<15yrs) per year. India accounts for highest number of children with T1D in South East Asian Region. Karnataka Diabetes Registry of T1D patients (1995 to 2008) reported an incidence of 3.8per 100,000 persons in India which is less when compared to Europe and other Western countries. Same study also reported that there is a huge gap between international standard of care and practice in India and that majority of T1D patients don't attain their glycemic targets.
Despite such unfavorable statistics, T1D does not receive adequate attention in terms of clinical and epidemiological research, achieving standards of practice and training of Medical practitioners. Many a times, it is also quoted as "Poor Cousin of Type 2 Diabetes".
A salient feature of T1D is its early onset and diagnosis (<20yrs of age) compared to type 2 diabetes. Consequently patients face longer duration of disease and greater glycemic exposure by the time they reach productive age and suffer chronic complications which are broadly classified into:
- Microvascular (retinopathy, neuropathy, and nephropathy) and
- Macrovascular [coronary artery disease (CAD), cerebrovascular disease (CVD), peripheral vascular disease (PVD)] .
These complications contribute to poor quality, substantial morbidity and premature mortality during prime years of life and premature death in T1D patients.
Limited studies are available from India on micro and macro-vascular complication of T1D.
Previous studies have detected that atherosclerotic process is accelerated in T1D population and western studies demonstrated a premature thickening of arterial Intima Media Thickness (IMT) within a short disease duration. Schuyler et al in 1976 for the first time suggested pulmonary complications among T1D. Since then limited attention has been given to lung as a target organ of diabetes even when lungs have a large vascular network. Studies have reported peripheral airway dysfunction and restrictive impairment of lung function even in the absence of smoking, allergies and other causes of airflow destruction among T1D patients. Screening for pulmonary complications among patients with T1D is currently not included in routine clinical settings. Growth parameters like standing height, weight are important indicators of a child's overall health and T1D patients are at an increased risk of developing growth failure. This is due to the role of insulin as a main regulator of Growth Hormone/Insulin Growth Factors (GH/IGF) axis and presence of portal insulin insufficiency among T1D patients. A recent study from Pune reported compromised growth in diabetic children when compared to matched controls. Impaired pre-pubertal and pubertal growth in children and adolescents has been reported in many studies. Factors like gender, age at diagnosis, puberty, metabolic control, insulin regime all affect growth. Bonfig et al 2012 observed a negative association between degree of metabolic control and impaired growth.
Risk factors for complications of T1D have been studied in Western population. Most of them report duration of disease, hyperglycemia, hypertension and dyslipidemia as predictors for micro and macro-vascular complications. But surprisingly "the 50-yr Medalist study" found no association of glycemic control with prevalence of micro-vascular complications.
Research Gap:
The public health burden of T1D is increasing in India and cannot be ignored. Studies assessing long-term complications of T1D from India are limited. They have relatively small sample size, are cross-sectional and retrospective in design. Incidence and progression of these complications has not been reported from India.Prevalence and progression of pulmonary complication among T1D patients has not been studied. Growth data in T1D patients is also limited and will benefit from our study.
Aims and Objectives :
Aim: This thesis will investigate prevalence; incidence and progression of micro-vascular, macro-vascular, pulmonary complications and growth failure among T1D patients in a clinic setting (specialty Diabetes Unit).
- OBJECTIVE 1 : To determine the prevalence of long-term complications among T1D patients.
- OBJECTIVE 2 : To determine the impact of factors like age, socio-economic status, body mass index (BMI), body fat (adiposity), duration of disease and glycemic control on the prevalence of complications.
- OBJECTIVE 3 :To document clinical progression of these complications in duration of 2 years.
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Prevalence, Incidence, Type 1 diabetes and its Micro-vascular complications, Type 1 diabetes and its Macro-vascular complications, Type 1 Diabetes and its complications in India
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Micro-vascular Complications.
Following tests will be performed for micro-vascular complications :
- RETINOPATHY: Retina scan images
- NEPHROPATHY:Urine Albumin : Creatinine ratio), Serum Creatinine, estimated glomerular filtration rate (eGFR)
- NEUROPATHY : Michigan Neuropathy Screening Instrument (MNSI) and Biothesiometer.
- Pulmonary : Spirometry
Prevalence will be reported as percentage i.e. number of cases divided by total number of study participants , multiplied by 100.
Measured: Assessed in one day, approximately.
Prevalence of Macro-vascular Complications.
Following tests will be performed for macro-vascular complications :
- Cardio-Vascular Disease :Blood pressure, Biochemical tests: Lipid Profile [Triglycerides, Cholesterol (HDL, LDL, total)] and ECG (Electrocardiogram > 15 years of age)
- Peripheral Vascular Disease : Ankle Brachial Index by Periscope
Prevalence will be reported as percentage i.e. number of cases divided by total number of study participants , multiplied by 100.
Measured: Assessed in one day, approximately.
Prevalence of Growth Complications.
Whole body Anthropometry and Pubertal staging by Tanner's method.
Measured: Assessed in one day, approximately.
Incidence of Micro-vascular, Macro-Vascular and Pulmonary Complications.
Same tools as listed for primary objective 1 will be utilised for measuring incidence of these complications.
- Incidence will be reported as number of new cases per year.
Measured: Assessed in one day, approximately.
Progression of Micro-vascular, Macro-Vascular and Pulmonary Complications.
Same tools as listed for primary objective 1 will be utilised for measuring incidence of these complications.
- Incidence will be reported as number of new cases per year.
Measured: Assessed in one day, approximately.
Secondary outcomes (1)
Association of Risk factors with prevalence of complications.
Risk factors are : BMI, Body fat, duration of disease, glycemic control (HbA1C), clinical history, family history, socio-economic status, Lifestyle related: Diet, Physical Activity and substance abuse, Body Composition : whole body Anthropometry and Dual Energy X-ray absorptiometry (DXA).
Risk factors will be used for multivariate analysis with the incidence and prevalence rates, also to report relative risks.
Measured: All this data will be collected at the time of primary objective 1 i.e. in one day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start10 Jun 2016
- Primary completion31 Aug 2019
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kem Hospital, Pune, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chittaranjan S Yajnik, King Edward Memorial Hospital
- Investigators
- Chittaranjan Yajnik, MD, FRCP, Principal investigator, KEMHRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069196
- Sponsor's protocol ID
- PhD 19
- Acronym
- PICTURE
- Status last verified
- Nov 2024
- First submitted
- 16 Feb 2017
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ziegler AG, Nepom GT. Prediction and pathogenesis in type 1 diabetes. Immunity. 2010 Apr 23;32(4):468-78. doi: 10.1016/j.immuni.2010.03.018.
PubMed 20412757Kumar KM. Incidence trends for childhood type 1 diabetes in India. Indian J Endocrinol Metab. 2015 Apr;19(Suppl 1):S34-5. doi: 10.4103/2230-8210.155378.
PubMed 25941646Kumar KM, Azad K, Zabeen B, Kalra S. Type 1 diabetes in children: Fighting for a place under the sun. Indian J Endocrinol Metab. 2012 Mar;16 Suppl 1(Suppl1):S1-3. doi: 10.4103/2230-8210.94241. No abstract available.
PubMed 22701826Walsh MG, Zgibor J, Borch-Johnsen K, Orchard TJ; DiaMond Investigators. A multinational comparison of complications assessment in type 1 diabetes: the DiaMond substudy of complications (DiaComp) level 2. Diabetes Care. 2004 Jul;27(7):1610-7. doi: 10.2337/diacare.27.7.1610.
PubMed 15220236Pickup, John C and Williams, Gareth, MD Textbook of diabetes (3rd ed). Blackwell Science, Malden, Mass. ; Oxford, U.K, 2003.
Patterson C, Guariguata L, Dahlquist G, Soltesz G, Ogle G, Silink M. Diabetes in the young - a global view and worldwide estimates of numbers of children with type 1 diabetes. Diabetes Res Clin Pract. 2014 Feb;103(2):161-75. doi: 10.1016/j.diabres.2013.11.005. Epub 2013 Dec 1.
PubMed 24331235Amutha A, Thai K, Vishwanathan M. Childhood and Adolescent ONset Type 1 Diabetes in India. MGM Journal of Medical Sciences. 2013; 1(1): p. 46-53.
Unnikrishnan AG, Bhatia E, Bhatia V, Bhadada SK, Sahay RK, Kannan A, Kumaravel V, Sarma D, Ganapathy B, Thomas N, John M, Jayakumar RV, Kumar H, Nair V, Sanjeevi CB. Type 1 diabetes versus type 2 diabetes with onset in persons younger than 20 years of age. Ann N Y Acad Sci. 2008 Dec;1150:239-44. doi: 10.1196/annals.1447.056.
PubMed 19120303Billow A, Anjana RM, Ngai M, Amutha A, Pradeepa R, Jebarani S, Unnikrishnan R, Michael E, Mohan V. Prevalence and clinical profile of metabolic syndrome among type 1 diabetes mellitus patients in southern India. J Diabetes Complications. 2015 Jul;29(5):659-64. doi: 10.1016/j.jdiacomp.2015.03.014. Epub 2015 Apr 6.
PubMed 25899474Ramachandran A, Snehalatha C, Sasikala R, Satyavani K, Vijay V. Vascular complications in young Asian Indian patients with type 1 diabetes mellitus. Diabetes Res Clin Pract. 2000 Apr;48(1):51-6. doi: 10.1016/s0168-8227(99)00134-5.
PubMed 10704700Laing SP, Swerdlow AJ, Slater SD, Burden AC, Morris A, Waugh NR, Gatling W, Bingley PJ, Patterson CC. Mortality from heart disease in a cohort of 23,000 patients with insulin-treated diabetes. Diabetologia. 2003 Jun;46(6):760-5. doi: 10.1007/s00125-003-1116-6. Epub 2003 May 28.
PubMed 12774166Dawson SI, Willis J, Florkowski CM, Scott RS. Cause-specific mortality in insulin-treated diabetic patients: a 20-year follow-up. Diabetes Res Clin Pract. 2008 Apr;80(1):16-23. doi: 10.1016/j.diabres.2007.10.034. Epub 2008 Mar 7.
PubMed 18329124Singh TP, Groehn H, Kazmers A. Vascular function and carotid intimal-medial thickness in children with insulin-dependent diabetes mellitus. J Am Coll Cardiol. 2003 Feb 19;41(4):661-5. doi: 10.1016/s0735-1097(02)02894-2.
PubMed 12598080Stakos DA, Schuster DP, Sparks EA, Wooley CF, Osei K, Boudoulas H. Cardiovascular effects of type 1 diabetes mellitus in children. Angiology. 2005 May-Jun;56(3):311-7. doi: 10.1177/000331970505600311.
PubMed 15889199Schuyler MR, Niewoehner DE, Inkley SR, Kohn R. Abnormal lung elasticity in juvenile diabetes mellitus. Am Rev Respir Dis. 1976 Jan;113(1):37-41. doi: 10.1164/arrd.1976.113.1.37.
PubMed 1247213
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Prevalence and Incidence of Long-term Complications of Type 1 Diabetes in a Tertiary Clinic in Pune.
- ClinicalTrials.gov ID
- NCT03069196
- Acronym / sponsor ID
- PICTURE / PhD 19
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Prevalence, Incidence, Type 1 diabetes and its Micro-vascular complications, Type 1 diabetes and its Macro-vascular complications, Type 1 Diabetes and its complications in India
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Kem Hospital, Pune, IndiaUniversity, hospital or other
- Study start
- 10 Jun 2016 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 3 Mar 2017 (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.
Due to early diagnosis (<20yrs of age) of Type 1 Diabetes, patients face longer duration of disease and greater glycemic exposure which makes them more vulnerable towards chronic complications. The aim of this study is to investigate the prevalence and incidence of micro and macro-vascular, pulmonary complications and patterns of growth failure in approximately 500 Type 1 Diabetes patients enrolled at Diabetes Unit, King Edward Memorial Hospital Research Centre. Then follow up of 100 participants who are above 15 years of age at baseline will be done after 2 years to document incidence and progression of complications. This will contribute in assessing the public health burden of complications of Type 1 Diabetes.
Factors associated with prevalence of complications will be investigated. This risk factor analysis could aid in further modifying current prevention and treatment recommendations of these complications. Results of this study could modify current clinical practice.
Detailed description
BACKGROUND \& RATIONALE OF THE STUDY:
Type 1 Diabetes (T1D) is characterized by progressive destruction of insulin secreting pancreatic β-cells. The commonest mechanism involves autoimmunity to components of β-cells. As per International Diabetes Federation report 2013, India houses 67,700 children (<15yrs) with T1D. It also states an approximate figure of 10,900 newly diagnosed T1D children (<15yrs) per year. India accounts for highest number of children with T1D in South East Asian Region. Karnataka Diabetes Registry of T1D patients (1995 to 2008) reported an incidence of 3.8per 100,000 persons in India which is less when compared to Europe and other Western countries. Same study also reported that there is a huge gap between international standard of care and practice in India and that majority of T1D patients don't attain their glycemic targets.
Despite such unfavorable statistics, T1D does not receive adequate attention in terms of clinical and epidemiological research, achieving standards of practice and training of Medical practitioners. Many a times, it is also quoted as "Poor Cousin of Type 2 Diabetes".
A salient feature of T1D is its early onset and diagnosis (<20yrs of age) compared to type 2 diabetes. Consequently patients face longer duration of disease and greater glycemic exposure by the time they reach productive age and suffer chronic complications which are broadly classified into:
- Microvascular (retinopathy, neuropathy, and nephropathy) and
- Macrovascular [coronary artery disease (CAD), cerebrovascular disease (CVD), peripheral vascular disease (PVD)] .
These complications contribute to poor quality, substantial morbidity and premature mortality during prime years of life and premature death in T1D patients.
Limited studies are available from India on micro and macro-vascular complication of T1D.
Previous studies have detected that atherosclerotic process is accelerated in T1D population and western studies demonstrated a premature thickening of arterial Intima Media Thickness (IMT) within a short disease duration. Schuyler et al in 1976 for the first time suggested pulmonary complications among T1D. Since then limited attention has been given to lung as a target organ of diabetes even when lungs have a large vascular network. Studies have reported peripheral airway dysfunction and restrictive impairment of lung function even in the absence of smoking, allergies and other causes of airflow destruction among T1D patients. Screening for pulmonary complications among patients with T1D is currently not included in routine clinical settings. Growth parameters like standing height, weight are important indicators of a child's overall health and T1D patients are at an increased risk of developing growth failure. This is due to the role of insulin as a main regulator of Growth Hormone/Insulin Growth Factors (GH/IGF) axis and presence of portal insulin insufficiency among T1D patients. A recent study from Pune reported compromised growth in diabetic children when compared to matched controls. Impaired pre-pubertal and pubertal growth in children and adolescents has been reported in many studies. Factors like gender, age at diagnosis, puberty, metabolic control, insulin regime all affect growth. Bonfig et al 2012 observed a negative association between degree of metabolic control and impaired growth.
Risk factors for complications of T1D have been studied in Western population. Most of them report duration of disease, hyperglycemia, hypertension and dyslipidemia as predictors for micro and macro-vascular complications. But surprisingly "the 50-yr Medalist study" found no association of glycemic control with prevalence of micro-vascular complications.
Research Gap:
The public health burden of T1D is increasing in India and cannot be ignored. Studies assessing long-term complications of T1D from India are limited. They have relatively small sample size, are cross-sectional and retrospective in design. Incidence and progression of these complications has not been reported from India.Prevalence and progression of pulmonary complication among T1D patients has not been studied. Growth data in T1D patients is also limited and will benefit from our study.
Aims and Objectives :
Aim: This thesis will investigate prevalence; incidence and progression of micro-vascular, macro-vascular, pulmonary complications and growth failure among T1D patients in a clinic setting (specialty Diabetes Unit).
- OBJECTIVE 1 : To determine the prevalence of long-term complications among T1D patients.
- OBJECTIVE 2 : To determine the impact of factors like age, socio-economic status, body mass index (BMI), body fat (adiposity), duration of disease and glycemic control on the prevalence of complications.
- OBJECTIVE 3 :To document clinical progression of these complications in duration of 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population includes those people who have been clinically diagnosed with Type 1 Diabetes. These participants will be selected from those enrolled at Diabetes Unit, KEMHRC, Pune, India.
Key inclusion criteria (4 listed)
- Type 1 Diabetes with a duration of diabetes more than 1 year.
- Willingness to participate in the study and sign the consent form.
- Age : all age groups
- Gender : Both
Key exclusion criteria (4 listed)
- Other forms of diabetes like Type 2 Diabetes, Gestational Diabetes, Fibro Calculus Pancreatic Disease (FCPD), Mature Onset of Diabetes in Young (MODY) etc.
- People with acute stages of diseases like pneumonia after being treated for the condition.
- Advanced end stage conditions like Cancer etc.
- Pregnant and lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Micro-vascular Complications.
Time frame: Assessed in one day, approximately.
Following tests will be performed for micro-vascular complications : 1. RETINOPATHY: Retina scan images 2. NEPHROPATHY:Urine Albumin : Creatinine ratio), Serum Creatinine, estimated glomerular filtration rate (eGFR) 3. NEUROPATHY : Michigan Neuropathy Screening Instrument (MNSI) and Biothesiometer. 4. Pulmonary : Spirometry Prevalence will be reported as percentage i.e. number of cases divided by total number of study participants , multiplied by 100.
Prevalence of Macro-vascular Complications.
Time frame: Assessed in one day, approximately.
Following tests will be performed for macro-vascular complications : 1. Cardio-Vascular Disease :Blood pressure, Biochemical tests: Lipid Profile [Triglycerides, Cholesterol (HDL, LDL, total)] and ECG (Electrocardiogram > 15 years of age) 2. Peripheral Vascular Disease : Ankle Brachial Index by Periscope Prevalence will be reported as percentage i.e. number of cases divided by total number of study participants , multiplied by 100.
Prevalence of Growth Complications.
Time frame: Assessed in one day, approximately.
Whole body Anthropometry and Pubertal staging by Tanner's method.
Incidence of Micro-vascular, Macro-Vascular and Pulmonary Complications.
Time frame: Assessed in one day, approximately.
Same tools as listed for primary objective 1 will be utilised for measuring incidence of these complications. - Incidence will be reported as number of new cases per year.
Progression of Micro-vascular, Macro-Vascular and Pulmonary Complications.
Time frame: Assessed in one day, approximately.
Same tools as listed for primary objective 1 will be utilised for measuring incidence of these complications. - Incidence will be reported as number of new cases per year.
1 secondary outcome
Association of Risk factors with prevalence of complications.
Time frame: All this data will be collected at the time of primary objective 1 i.e. in one day.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Background: PubMed 20412757Ziegler AG, Nepom GT. Prediction and pathogenesis in type 1 diabetes. Immunity. 2010 Apr 23;32(4):468-78. doi: 10.1016/j.immuni.2010.03.018.
- Background: PubMed 25941646Kumar KM. Incidence trends for childhood type 1 diabetes in India. Indian J Endocrinol Metab. 2015 Apr;19(Suppl 1):S34-5. doi: 10.4103/2230-8210.155378.
- Background: PubMed 22701826Kumar KM, Azad K, Zabeen B, Kalra S. Type 1 diabetes in children: Fighting for a place under the sun. Indian J Endocrinol Metab. 2012 Mar;16 Suppl 1(Suppl1):S1-3. doi: 10.4103/2230-8210.94241. No abstract available.
- Background: PubMed 15220236Walsh MG, Zgibor J, Borch-Johnsen K, Orchard TJ; DiaMond Investigators. A multinational comparison of complications assessment in type 1 diabetes: the DiaMond substudy of complications (DiaComp) level 2. Diabetes Care. 2004 Jul;27(7):1610-7. doi: 10.2337/diacare.27.7.1610.
- BackgroundPickup, John C and Williams, Gareth, MD Textbook of diabetes (3rd ed). Blackwell Science, Malden, Mass. ; Oxford, U.K, 2003.
- Background: PubMed 24331235Patterson C, Guariguata L, Dahlquist G, Soltesz G, Ogle G, Silink M. Diabetes in the young - a global view and worldwide estimates of numbers of children with type 1 diabetes. Diabetes Res Clin Pract. 2014 Feb;103(2):161-75. doi: 10.1016/j.diabres.2013.11.005. Epub 2013 Dec 1.
- BackgroundAmutha A, Thai K, Vishwanathan M. Childhood and Adolescent ONset Type 1 Diabetes in India. MGM Journal of Medical Sciences. 2013; 1(1): p. 46-53.
- Background: PubMed 19120303Unnikrishnan AG, Bhatia E, Bhatia V, Bhadada SK, Sahay RK, Kannan A, Kumaravel V, Sarma D, Ganapathy B, Thomas N, John M, Jayakumar RV, Kumar H, Nair V, Sanjeevi CB. Type 1 diabetes versus type 2 diabetes with onset in persons younger than 20 years of age. Ann N Y Acad Sci. 2008 Dec;1150:239-44. doi: 10.1196/annals.1447.056.
- Background: PubMed 25899474Billow A, Anjana RM, Ngai M, Amutha A, Pradeepa R, Jebarani S, Unnikrishnan R, Michael E, Mohan V. Prevalence and clinical profile of metabolic syndrome among type 1 diabetes mellitus patients in southern India. J Diabetes Complications. 2015 Jul;29(5):659-64. doi: 10.1016/j.jdiacomp.2015.03.014. Epub 2015 Apr 6.
- Background: PubMed 10704700Ramachandran A, Snehalatha C, Sasikala R, Satyavani K, Vijay V. Vascular complications in young Asian Indian patients with type 1 diabetes mellitus. Diabetes Res Clin Pract. 2000 Apr;48(1):51-6. doi: 10.1016/s0168-8227(99)00134-5.
- Background: PubMed 12774166Laing SP, Swerdlow AJ, Slater SD, Burden AC, Morris A, Waugh NR, Gatling W, Bingley PJ, Patterson CC. Mortality from heart disease in a cohort of 23,000 patients with insulin-treated diabetes. Diabetologia. 2003 Jun;46(6):760-5. doi: 10.1007/s00125-003-1116-6. Epub 2003 May 28.
- Background: PubMed 18329124Dawson SI, Willis J, Florkowski CM, Scott RS. Cause-specific mortality in insulin-treated diabetic patients: a 20-year follow-up. Diabetes Res Clin Pract. 2008 Apr;80(1):16-23. doi: 10.1016/j.diabres.2007.10.034. Epub 2008 Mar 7.
- Individual participant dataSharing planned: Undecided
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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.
Chittaranjan Yajnik, MD, FRCP principal investigator
KEMHRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by Kem Hospital, Pune, India at 1 site in India.
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 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: under way, not looking for participants, as of the sponsor's last update on 12 Nov 2024. 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 India. 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?
This study is still under way. Results are not available in the source record yet.
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?
Prevalence of Micro-vascular Complications. (time frame: Assessed in one day, approximately.). The study lists 5 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 NCT03069196, which also lists 23 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 12 Nov 2024.