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Completed

NCT Number: NCT04453605

Phenotyping Individuals With Neo-diagnosed Type 2 Diabetes at Risk for All-cause Mortality

Prevalence of type 2 diabetes (T2D) is increasing worldwide over the last two decades; in these patients the rate of all-cause and cardiovascular (CV) mortality is several folds higher than in the general population, configuring a major public health problem. The clinical phenotype is the main determinant of such high mortality risk; however, a relevant role is played by the disease duration, with a significant interaction with metabolic control. However, for T2D the diagnosis does not correspond to the true onset of the disease, and a high lethality rate also in patients with recent onset of the disease cannot be excluded. Robust evidence supports this hypothesis, showing as in subjects with new-onset T2D, the mortality risk is superimposable, and even higher, than that observed in people with overt and long-term T2D. In this complex scenario, it would be desirable an early identification of high-risk patients, in which an accurate estimation of risk of complications, coupled with appropriate and timely interventions, might help in reducing the risk of encountering premature mortality. The present study was design to address this specific issue.

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Key information

Conditions

Type 2 Diabetes Cardiac Disease Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pisa

Pisa, 56125, Italy

About this study

Patients referring for the first time to the outpatient diabetes clinic in the department of Internal Medicine between January 2008 and December 2015 and matching the inclusion criteria were recruited.

Diagnosis was confirmed on the basis of the Oral Glucose Tolerance Test (OGTT) or HbA1c ≥6.5% plus fasting blood glucose ≥126 mg/dl.

Anthropometric measurements were recorded, arterial pressure and vital parameters were registered, and blood samples were collected for routine analyses. Complete blood count, glucose, HbA1c, Serum Glutamic Oxaloacetic Transaminase (sGOT), Serum Glutamic Pyruvic Transaminase (sGPT), uric acid, were determined by standard techniques. Total and HDL cholesterol and triglycerides were assayed through the automated spectrophotometer, enzymatic colorimetric method, COBAS INTEGRA using commercial kits (Roche Diagnostics). Serum creatinine was measured by Jaffe' method, and estimated glomerular filtration rate (eGFR) was calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

Previous major acute CV events, including myocardial infarction, stroke, foot ulcer/gangrene/amputation and coronary, carotid and lower limb revascularisation, were adjudicated based on hospital discharge records.

At the end of the baseline visit, patients were treated according to the good clinical practice recommended by the international guidelines, and followed a six-month or an yearly calendar of follow-up visits, until death or until 31 December 2018. All-cause mortality was assessed by checking the vital status of study participants on 31 December 2018; to this aim, investigators interrogated the Italian Health Card database, which provides updated information on all current Italian residents.

Incident major acute cardiovascular events were registered on the basis of clinical records every year; retinopathy onset was assessed by fundoscopy on a yearly basis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥30 years
  • personal history of known T2D lasting not more than six months
  • diagnosis confirmed on the basis of the OGTT or HbA1c ≥6.5% plus fasting blood glucose ≥126 mg/dl

Exclusion criteria

  • longstanding disease duration
  • type 1 diabetes
  • diabetes secondary to steroid therapy
  • active cancer

Treatment and study plan

standard treatments

Other

patients were treated according to the good clinical practice recommended by the international guidelines, and followed a six-month or an yearly calendar of follow-up visits

Primary outcomes

  1. Number of participants who died during the study

    Time frame: At 31 December 2018

    The number of participants who died during the study was assessed by checking the vital status of study participants on 31 December 2018; to this aim, we interrogated the Italian Health Card database, which provides updated information on all current Italian residents.

  2. Incidence of cardiovascular disease

    Time frame: At 31 December 2018

    Incident major acute cardiovascular events were registered on the basis of clinical records every year

  3. Incidence of microvascular complication

    Time frame: At 31 December 2018

    Retinopathy onset was assessed by fundoscopy on a yearly basis.

Secondary outcomes

  1. Change of renal function through study completion (an average of 5 year)

    Time frame: From baseline until the end of observation or the date of death from any cause, whichever came first, assessed up to 60 months.

    Serum creatinine was measured by Jaffe' method and expressed by mg/dl. It was used to calculate eGFR according to the CKD-EPI formula.

  2. Change of blood glucose through study completion (an average of 5 year)

    Time frame: From baseline until the end of observation or the date of death from any cause, whichever came first, assessed up to 60 months.

    Blood glucose was expressed in mg/dl and was determined by standard techniques.

  3. Change of HbA1c through study completion (an average of 5 year)

    Time frame: From baseline until the end of observation or the date of death from any cause, whichever came first, assessed up to 60 months.

    HbA1c was expressed as percentage or mmol/l and was determined by standard techniques.

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

Determining All Cause Morality and Cardiovascular Mortality Risk in Individuals With Neo-diagnosed Type 2 Diabetes

Important dates

Study start
2008
Primary completion
2015
Study completion
2018
First posted
Jul 1, 2020
Registry last updated
Jul 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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