Type-1 DiabetesHolter GlyNCT02862860
Search for a Link Between the Different Variables for Glycaemia and Oxidative Stress or Impaired HDL Function
A study testing blood sample, urine sample and installation of Holter in people with Type-1 Diabetes, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
As glycaemic variability on the one hand and hypoglycaemia on the other are associated with oxidative stress and inflammation, they are likely, in type-1 diabetic patients, to affect the oxidation of lipoproteins and HDL function, by altering their anti-atherogenic properties. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type-1 Diabetes
- What is being tested?
- blood sample, urine sample and installation of Holter
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 29 May 2012to 17 Apr 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who have provided written consent
- Patients with national health insurance cover
- Patients with T1D
- T1D Patients treated with insulin via a pump or multiple injections
- HbA1c < 9.5 %
- Control patients
Show all 13Show fewer
- Normal fasting glycaemia (< 6.1 mmol/L)
- Age > 18 years, matched for sex and age with T1D patients
- All patients
- Normal serum HDL cholesterol (> 1.04 mmol/L in men, > 1.30 mmol:L in women)
- Serum LDL cholesterol < 5 mmol/L
- triglyceridemia < 1.7 mmol/L
- Waist circumference < 102 cm in men, < 88 cm in women
Who cannot join
- Smoking
- Kidney failure (Creatinine clearance< 60 ml/min/1.73 m2)
- Liver failure
- Dysthyroidism
- Medication that interferes with lipoprotein metabolism (lipid-lowering agents, oestroprogestative, anti-HIV, corticoids, retinoic acid), unless stopped for at least one 1 month
- Antioxidant (vitamin E, dietary supplements, DHA)
- Pregnancy of more than 15d
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Glycaemic Variability on Oxidative Stress and High-density Lipoprotein (HDL) Function in Type-1 Diabetes
As glycaemic variability on the one hand and hypoglycaemia on the other are associated with oxidative stress and inflammation, they are likely, in type-1 diabetic patients, to affect the oxidation of lipoproteins and HDL function, by altering their anti-atherogenic properties.
The aim of this study is thus to determine, in patients with Type 1 Diabetic (T1D) who will wear a glycaemic Holter for 1 week, the glycaemia parameters (mean glycaemia, duration of hypoglycaemia, duration of hyperglycaemia, mean amplitude of glycaemic excursions) associated with proatherogenic alterations in lipoproteins, in particular:
- LDL oxidation
- HDL oxidation and alterations of HDL function (anti-inflammatory capacity, antioxidant capacity)
- Conditions
- Type-1 Diabetes
- Being tested
- blood sample, urine sample, installation of Holter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
urine sampleBiological
installation of HolterDevice
| Study group | Role | What they receive |
|---|---|---|
| patients with type-1 diabetes | Experimental | Not described Receives: Biological: blood sample; Biological: urine sample; Device: installation of Holter |
| Controls | Placebo comparator | Not described Receives: Biological: blood sample; Biological: urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average blood glucose
Measured: through study completion, an average of 7 days
Time hypoglycemia
Measured: through study completion, an average of 7 days
Time hyperglycemia
Measured: through study completion, an average of 7 days
Amplitude of glycemic variations
Measured: through study completion, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start29 May 2012
- Primary completion17 Apr 2018
- Study completion17 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type-1 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862860
- Sponsor's protocol ID
- Duvillard Hors AOI 2011
- Acronym
- Holter Gly
- Status last verified
- Feb 2024
- First submitted
- 28 Jul 2016
- Last updated
- 21 Feb 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Glycaemic Variability on Oxidative Stress and High-density Lipoprotein (HDL) Function in Type-1 Diabetes
- ClinicalTrials.gov ID
- NCT02862860
- Acronym / sponsor ID
- Holter Gly / Duvillard Hors AOI 2011
- Conditions
- Type-1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 29 May 2012 (actual)
- Primary completion
- 17 Apr 2018 (actual)
- Study completion
- 17 Apr 2018 (actual)
- First posted
- 11 Aug 2016 (estimated)
- 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.
As glycaemic variability on the one hand and hypoglycaemia on the other are associated with oxidative stress and inflammation, they are likely, in type-1 diabetic patients, to affect the oxidation of lipoproteins and HDL function, by altering their anti-atherogenic properties.
The aim of this study is thus to determine, in patients with Type 1 Diabetic (T1D) who will wear a glycaemic Holter for 1 week, the glycaemia parameters (mean glycaemia, duration of hypoglycaemia, duration of hyperglycaemia, mean amplitude of glycaemic excursions) associated with proatherogenic alterations in lipoproteins, in particular:
- LDL oxidation
- HDL oxidation and alterations of HDL function (anti-inflammatory capacity, antioxidant capacity)
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with type-1 diabetes | Experimental | Biological: blood sample, Biological: urine sample, Device: installation of Holter |
| Controls | Placebo comparator | Biological: blood sample, Biological: urine sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients who have provided written consent
- Patients with national health insurance cover
- Patients with T1D
- T1D Patients treated with insulin via a pump or multiple injections
- HbA1c < 9.5 %
Key exclusion criteria (7 listed)
- Smoking
- Kidney failure (Creatinine clearance< 60 ml/min/1.73 m2)
- Liver failure
- Dysthyroidism
- Medication that interferes with lipoprotein metabolism (lipid-lowering agents, oestroprogestative, anti-HIV, corticoids, retinoic acid), unless stopped for at least one 1 month
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 |
|---|---|---|
| blood sample | Biological | Controls, patients with type-1 diabetes |
| urine sample | Biological | Controls, patients with type-1 diabetes |
| installation of Holter | Device | patients with type-1 diabetes |
Primary outcome
Average blood glucose
Time frame: through study completion, an average of 7 days
Time hypoglycemia
Time frame: through study completion, an average of 7 days
Time hyperglycemia
Time frame: through study completion, an average of 7 days
Amplitude of glycemic variations
Time frame: through study completion, an average of 7 days
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 21 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample, urine sample and installation of Holter in people with Type-1 Diabetes, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 13 inclusion and 7 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 21 Feb 2024. 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 France. 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. Some participants in this study may receive a placebo. 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?
Average blood glucose (time frame: through study completion, an average of 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2024.