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Prevalence and Incidence of Complications of Type One Diabetes in pUne at a Tertiary Care centRE (PICTURE)

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ClinicalTrials.gov Identifier: NCT03069196
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Chittaranjan S Yajnik, King Edward Memorial Hospital

Brief 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. 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.


Condition or disease
Type 1 Diabetes Mellitus

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study to Assess Prevalence and Incidence of Long-term Complications of Type 1 Diabetes in a Tertiary Clinic in Pune.
Actual Study Start Date : June 10, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1




Primary Outcome Measures :
  1. 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.


  2. 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.


  3. Prevalence of Growth Complications. [ Time Frame: Assessed in one day, approximately. ]
    Whole body Anthropometry and Pubertal staging by Tanner's method.

  4. 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.


  5. 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.



Secondary Outcome Measures :
  1. 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. ]

    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.



Biospecimen Retention:   Samples With DNA
For future biochemical tests : Plasma, Serum and Urine samples are stored. To do DNA extraction at a later stage Packed cells are stored.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03069196


Contacts
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Contact: Chittaranjan S Yajnik, MD , FRCP 020-26061958 csyajnik@gmail.com
Contact: Alma Baptist, MSc +91-8390689727 alma.baptist@gmail.com

Locations
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India
Diabetes Unit, Kem Hospital Research Centre Recruiting
Pune, Maharashtra, India, 411014
Contact: Chittaranjan S Yajnik, MD         
Principal Investigator: Chittaranjan S Yajnik, MD , FRCP         
Sponsors and Collaborators
Kem Hospital, Pune, India
Investigators
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Principal Investigator: Chittaranjan Yajnik, MD , FRCP KEMHRC

Publications:
Pickup, John C and Williams, Gareth, MD Textbook of diabetes (3rd ed). Blackwell Science, Malden, Mass. ; Oxford, U.K, 2003.
Amutha 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.

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Responsible Party: Dr. Chittaranjan S Yajnik, Professor Dr., King Edward Memorial Hospital
ClinicalTrials.gov Identifier: NCT03069196     History of Changes
Other Study ID Numbers: PhD 19
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Chittaranjan S Yajnik, King Edward Memorial Hospital:
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

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases