Clinical trial NCT03069196: Prevalence and Incidence of Complications of Type One Diabetes in PUne At a Tertiary Care CentRE
Official title: A Study to Assess Prevalence and Incidence of Long-term Complications of Type 1 Diabetes in a Tertiary Clinic in Pune.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Kem Hospital, Pune, India
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 323
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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:

1. Microvascular (retinopathy, neuropathy, and nephropathy) and
2. 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).

1. OBJECTIVE 1 : To determine the prevalence of long-term complications among T1D patients.
2. 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.
3. OBJECTIVE 3 :To document clinical progression of these complications in duration of 2 years.

Eligibility 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

Primary outcomes:
measure: Prevalence of Micro-vascular Complications.
timeFrame: Assessed in one day, approximately.
measure: Prevalence of Macro-vascular Complications.
timeFrame: Assessed in one day, approximately.
measure: Prevalence of Growth Complications.
timeFrame: Assessed in one day, approximately.
measure: Incidence of Micro-vascular, Macro-Vascular and Pulmonary Complications.
timeFrame: Assessed in one day, approximately.
measure: Progression of Micro-vascular, Macro-Vascular and Pulmonary Complications.
timeFrame: Assessed in one day, approximately.
Secondary outcomes:
measure: Association of Risk factors with prevalence of complications.
timeFrame: All this data will be collected at the time of primary objective 1 i.e. in one day.
Other outcomes:
Locations:
city: Pune
country: India
facility: Diabetes Unit, Kem Hospital Research Centre
state: Maharashtra
Study officials:
affiliation: KEMHRC
name: Chittaranjan Yajnik, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
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