Prevalence and Incidence of Complications of Type One Diabetes in PUne At a Tertiary Care CentRE

NCT03069196 | Active Not Recruiting

• 1 other identifier: PhD 19
• Study Type: observational
• Target: 323
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• Prevalence of Micro-vascular Complications.

  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.

  Assessed in one day, approximately.

• Prevalence of Macro-vascular Complications.

  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.

  Assessed in one day, approximately.

• Prevalence of Growth Complications.

  Whole body Anthropometry and Pubertal staging by Tanner's method.

  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.

  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.

  Assessed in one day, approximately.

Secondary Outcomes (1)

• Association of Risk factors with prevalence of complications.

  All this data will be collected at the time of primary objective 1 i.e. in one day.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kem Hospital, Pune, India: lead

Study Sites (1)

Diabetes Unit, Kem Hospital Research Centre

Pune, Maharashtra, 411014, India

Location

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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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Chittaranjan Yajnik, MD, FRCP

  KEMHRC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: March 3, 2017
• Study Start: June 10, 2016
• Primary Completion: August 31, 2019
• Study Completion: December 30, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

IN (1)