NCT04501991

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2020

Completed
Last Updated

August 6, 2020

Status Verified

August 1, 2020

Enrollment Period

2 months

First QC Date

August 5, 2020

Last Update Submit

August 5, 2020

Conditions

Type 2 DiabetesMetabolic Control

Keywords

T2DSars-Cov-2COVID-19 lockdownmetabolic controlsedentary

Outcome Measures

Primary Outcomes (3)

  • Glucose

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

    One week after the end of the lockdown period

  • HbA1c

    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

    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

Study Arms (1)

Patients with Type 2 Diabetes

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

Other: antidiabetic treatment

Interventions

antidiabetic treatmentOTHER

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

Patients with Type 2 Diabetes

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pisa

Pisa, 56125, Italy

Location

Related Publications (5)

  • 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.

    PMID: 32466106BACKGROUND

  • 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.

    PMID: 32395187BACKGROUND

  • 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.

    PMID: 32416527BACKGROUND

  • 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.

    PMID: 32466598BACKGROUND

  • 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.

    PMID: 32513197BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Sedentary Behavior

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Anna Solini, MD, PhD

    University of Pisa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 5, 2020

First Posted

August 6, 2020

Study Start

March 11, 2020

Primary Completion

May 4, 2020

Study Completion

June 30, 2020

Last Updated

August 6, 2020

Record last verified: 2020-08

Locations

IT(1)