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

August 5, 2020 updated by: Anna Solini, University of Pisa

Determining the Impact of COVID-19 Lockdown on Metabolic Control in Individuals With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pisa, Italy, 56125
        • University of Pisa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All the patients with type 2 diabetes, regularly referring (with at least two previous clinical records in the last two years) to the outpatient diabetes clinic of Internal Medicine section, University Hospital in Pisa, and who were previously scheduled for a follow-up visit during the lockdown for COVID-19 (March 9, 2020-May 04, 2020) were screened for this observational study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Type 2 Diabetes
Patients with type 2 diabetes and a scheduled visit during the lockdown for COVID-19
Other: antidiabetic treatment
Every kind of antidiabetic treatment, oral or injective, were considered including patients treated only with diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One week after the end of the lockdown period
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.
One week after the end of the lockdown period
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.
One week after the end of the lockdown period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pisa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2020

Primary Completion (Actual)

May 4, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

August 5, 2020

First Submitted That Met QC Criteria

August 5, 2020

First Posted (Actual)

August 6, 2020

Study Record Updates

Last Update Posted (Actual)

August 6, 2020

Last Update Submitted That Met QC Criteria

August 5, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AS0007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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