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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04501991
• Other study ID #: AS0007
• Status: Completed
• Start date: March 11, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2020
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: June 30, 2020
• Est. primary completion date: May 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Metabolic Control
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Italy	University of Pisa	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Bonora BM, Boscari F, Avogaro A, Bruttomesso D, Fadini GP. Glycaemic Control Among People with Type 1 Diabetes During Lockdown for the SARS-CoV-2 Outbreak in Italy. Diabetes Ther. 2020 May 11:1-11. doi: 10.1007/s13300-020-00829-7. [Epub ahead of print] — View Citation

Di Renzo L, Gualtieri P, Pivari F, Soldati L, Attinà A, Cinelli G, Leggeri C, Caparello G, Barrea L, Scerbo F, Esposito E, De Lorenzo A. Eating habits and lifestyle changes during COVID-19 lockdown: an Italian survey. J Transl Med. 2020 Jun 8;18(1):229. doi: 10.1186/s12967-020-02399-5. — View Citation

Martinez-Ferran M, de la Guía-Galipienso F, Sanchis-Gomar F, Pareja-Galeano H. Metabolic Impacts of Confinement during the COVID-19 Pandemic Due to Modified Diet and Physical Activity Habits. Nutrients. 2020 May 26;12(6). pii: E1549. doi: 10.3390/nu12061549. Review. — View Citation

Nachimuthu S, Vijayalakshmi R, Sudha M, Viswanathan V. Coping with diabetes during the COVID - 19 lockdown in India: Results of an online pilot survey. Diabetes Metab Syndr. 2020 Jul - Aug;14(4):579-582. doi: 10.1016/j.dsx.2020.04.053. Epub 2020 May 11. — View Citation

Scarmozzino F, Visioli F. Covid-19 and the Subsequent Lockdown Modified Dietary Habits of Almost Half the Population in an Italian Sample. Foods. 2020 May 25;9(5). pii: E675. doi: 10.3390/foods9050675. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose	Blood glucose was expressed in mg/dl and was determined by standard techniques.	One week after the end of the lockdown period
Primary	HbA1c	HbA1c was expressed as percentage or mmol/l and was determined by standard techniques.	One week after the end of the lockdown period
Primary	Lipid profile	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