Skip to main content
OpenTrials
Completed

NCT Number: NCT04501991

Short-term Impact of COVID-19 Lockdown on Metabolic Control of Type 2 Diabetes

The strict rules applied in Italy during the recent COVID-19 pandemic, with the prohibition to attend any regular outdoor activity, are likely to influence the degree of metabolic control of patients with type 2 diabetes. The aim of this observational, prospective, single centre study was to evaluate the immediate impact of the lockdown rules on the metabolic profile of a cohort of patients with type 2 diabetes.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Control Metabolic Diseases Nutritional and Metabolic Diseases Sedentary Behavior

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pisa

Pisa, 56125, Italy

About this study

All the patients with type 2 diabetes who were previously scheduled for a follow-up visit in our outpatient diabetes clinic during the lockdown for COVID-19 (March 9, 2020-May 04, 2020) were contacted by phone. Patients who accepted to take part of the study received a medical prescription for routine analysis via email. They were asked to perform blood drawing one week after the end of the lockdown period and transmitted us the results.

We then compared the metabolic profile tested one week after the end of the lockdown with the last value and the mean of the last three determinations performed before the pandemic emergency.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • type 2 diabetes
  • at least two previous clinical records in the last two years

Exclusion criteria

  • age >85 years
  • first access to the outpatient clinic
  • type 1 diabetes

Treatment and study plan

antidiabetic treatment

Other

Every kind of antidiabetic treatment, oral or injective, were considered including patients treated only with diet

Primary outcomes

  1. Glucose

    Time frame: One week after the end of the lockdown period

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

  2. HbA1c

    Time frame: One week after the end of the lockdown period

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

  3. Lipid profile

    Time frame: One week after the end of the lockdown period

    Complete lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol, Triglcerydes) were expressed in mg/dl or mmol/l and were determined by standard techniques.

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

Determining the Impact of COVID-19 Lockdown on Metabolic Control in Individuals With Type 2 Diabetes

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 6, 2020
Registry last updated
Aug 6, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.