Type 2 DiabetesNCT04501991
Short-term Impact of COVID-19 Lockdown on Metabolic Control of Type 2 Diabetes
An observational study of Type 2 Diabetes and Metabolic Control, run by University of Pisa at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Type 2 Diabetes, Metabolic Control
- What is being tested?
- antidiabetic treatment
- Type of treatment
- Pill or oral medicine
- How many people
- 114 participants
- Where
- 1 siteItaly
- Study dates
- 11 Mar 2020to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- type 2 diabetes
- at least two previous clinical records in the last two years
Who cannot join
- age >85 years
- first access to the outpatient clinic
- type 1 diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Impact of COVID-19 Lockdown on Metabolic Control in Individuals With Type 2 Diabetes
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.
Read the 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.
- Conditions
- Type 2 Diabetes, Metabolic Control
- Being tested
- antidiabetic treatment
- Keywords
- T2D, Sars-Cov-2, COVID-19 lockdown, metabolic control, sedentary
- Medical subject headings
- Diabetes Mellitus, Type 2, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antidiabetic treatmentOther
Every kind of antidiabetic treatment, oral or injective, were considered including patients treated only with diet
| Study group | Role | What they receive |
|---|---|---|
| Patients with Type 2 Diabetes | Patients with type 2 diabetes and a scheduled visit during the lockdown for COVID-19 Receives: Other: antidiabetic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose
Blood glucose was expressed in mg/dl and was determined by standard techniques.
Measured: One week after the end of the lockdown period
HbA1c
HbA1c was expressed as percentage or mmol/l and was determined by standard techniques.
Measured: 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.
Measured: One week after the end of the lockdown period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start11 Mar 2020
- Primary completion4 May 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Solini, University of Pisa
- Investigators
- Anna Solini, MD, PhD, Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501991
- Sponsor's protocol ID
- AS0007
- Status last verified
- Aug 2020
- First submitted
- 5 Aug 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32466106Bonora 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.
PubMed 32395187Nachimuthu 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.
PubMed 32416527Martinez-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.
PubMed 32466598Di 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.
PubMed 32513197
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Impact of COVID-19 Lockdown on Metabolic Control in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04501991
- Acronym / sponsor ID
- AS0007
- Conditions
- Type 2 Diabetes, Metabolic Control
- Keywords
- T2D, Sars-Cov-2, COVID-19 lockdown, metabolic control, sedentary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 4 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Type 2 Diabetes | – | Other: antidiabetic treatmentPatients with type 2 diabetes and a scheduled visit during the lockdown for COVID-19 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- type 2 diabetes
- at least two previous clinical records in the last two years
Key exclusion criteria (3 listed)
- age >85 years
- first access to the outpatient clinic
- type 1 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antidiabetic treatmentEvery kind of antidiabetic treatment, oral or injective, were considered including patients treated only with diet | Other | Patients with Type 2 Diabetes |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Background: PubMed 32466106Scarmozzino 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.
- Background: PubMed 32395187Bonora 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.
- Background: PubMed 32416527Nachimuthu 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.
- Background: PubMed 32466598Martinez-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.
- Background: PubMed 32513197Di 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Solini, MD, PhD principal investigator
University of Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Metabolic Control, run by University of Pisa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose (time frame: One week after the end of the lockdown period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04501991, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.