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

NCT ID: NCT04501991

Last Updated: 2020-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-11

Study Completion Date

2020-06-30

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Metabolic Control

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with Type 2 Diabetes

Patients with type 2 diabetes and a scheduled visit during the lockdown for COVID-19

antidiabetic treatment

Intervention Type OTHER

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

Interventions

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antidiabetic treatment

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pisa

OTHER

Sponsor Role lead

Responsible Party

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Anna Solini

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Solini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pisa

Locations

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University of Pisa

Pisa, , Italy

Site Status

Countries

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Italy

References

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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):675. doi: 10.3390/foods9050675.

Reference Type BACKGROUND
PMID: 32466106 (View on PubMed)

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 Jun;11(6):1369-1379. doi: 10.1007/s13300-020-00829-7. Epub 2020 May 11.

Reference Type BACKGROUND
PMID: 32395187 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32416527 (View on PubMed)

Martinez-Ferran M, de la Guia-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):1549. doi: 10.3390/nu12061549.

Reference Type BACKGROUND
PMID: 32466598 (View on PubMed)

Di Renzo L, Gualtieri P, Pivari F, Soldati L, Attina 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.

Reference Type BACKGROUND
PMID: 32513197 (View on PubMed)

Other Identifiers

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AS0007

Identifier Type: -

Identifier Source: org_study_id

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