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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04501991
Recruitment Status : Completed
First Posted : August 6, 2020
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Anna Solini, 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.

Condition or disease Intervention/treatment
Type 2 Diabetes Metabolic Control Other: antidiabetic 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.

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Study Type : Observational
Actual Enrollment : 114 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Determining the Impact of COVID-19 Lockdown on Metabolic Control in Individuals With Type 2 Diabetes
Actual Study Start Date : March 11, 2020
Actual Primary Completion Date : May 4, 2020
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04501991


Locations
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Italy
University of Pisa
Pisa, Italy, 56125
Sponsors and Collaborators
University of Pisa
Investigators
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Principal Investigator: Anna Solini, MD, PhD University of Pisa
Publications:
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Responsible Party: Anna Solini, Associate Professor, University of Pisa
ClinicalTrials.gov Identifier: NCT04501991    
Other Study ID Numbers: AS0007
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Solini, University of Pisa:
T2D
Sars-Cov-2
COVID-19 lockdown
metabolic control
sedentary
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs