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

Completed

• Conditions: Metabolic Control; Type 2 Diabetes

• Registration Number: NCT04501991
• Lead Sponsor: University of Pisa

Brief Summary

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.

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 Timeline

• Study Start: 2020-03-11
• Primary Completion: 2020-05-04
• Study Completion: 2020-06-30
• Status Verified: 2020-08
• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-05
• Last Update Submitted: 2020-08-05
• Study First Posted: 2020-08-06
• Last Update Posted: 2020-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lipid profile	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.
Glucose	One week after the end of the lockdown period	Blood glucose was expressed in mg/dl and was determined by standard techniques.
HbA1c	One week after the end of the lockdown period	HbA1c was expressed as percentage or mmol/l and was determined by standard techniques.

Trial Locations

Locations (1)

University of Pisa; 🇮🇹 Pisa, Italy