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AzTrials

Type 1 DiabetesDIAPASOMNCT00805974

Study of the Relationship Between Sleep Quality and Daytime-Nighttime Variations of Blood Pressure and Plasma Glucose Type I

A study testing Biological examinations (blood and urinary). in people with Type 1 Diabetes, run by University Hospital, Grenoble at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objectives are to compare the mean levels of the sleep quality parameters of subjects : with a nocturnal fall of the SBP (Systolic blood pressure), DBP (diastolic blood pressure) and MAP (mean arterial pressure) over of egal to 10% (dipping subjects) and of subjects with a nocturnal fall of SBP, DBP and… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Biological examinations (blood and urinary).
How many people
23 participants
Where
1 siteFrance
Study dates
Oct 2005to Dec 2007
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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male and female patients between 18 and 60 years of age
  • Who have given their written consent to participate in this study
  • Who are affiliated to the French social security system
  • Are able to travel to Grenoble University Hospital
  • Type I diabetes in reference to the 1997 criteria (American Diabetes Association) without any recent cetoacidosis or severe hypoglycaemia during the previous month and with a HbA1c < 10% during the previous month.
  • Normal blood pressure or essential hypertension light or moderate (SBP) at rest in the sitting position >= 140 mmHg and < 180 mmHg and/or PAD >= 90 mmHg et < 110 mmHg), with or without treatment.

Who cannot join

  • Non stabilised diabetes with at least one episode of acidoketosis decompensation or hypoglycemic coma during the previous month.
  • Diabetic nephropathy patent stage 4 with a creatinine > 150 mol / L and / or creatinine clearance <50 ml / min
  • Diabetic nephropathy in evolution
  • Severe hypertension (SBP at rest in the sitting position >= 180 mmHg and/or DBP >= 110 mmHg)

Trial locations and contacts

1 site in 1 country.

France1 site

  • University Hospital

    Grenoble

Other trials in France

About this study

The primary objectives are to compare the mean levels of the sleep quality parameters of subjects : with a nocturnal fall of the SBP (Systolic blood pressure), DBP (diastolic blood pressure) and MAP (mean arterial pressure) over of egal to 10% (dipping subjects) and of subjects with a nocturnal fall of SBP, DBP and MAP inferior to 10% (non dipper subjects).

The secondary objectives are :

Read more

Establish correlations between:

  • The quality of sleep parameters
  • The parameters of BP variations between the diurnal and nocturnal periods and the awake periods of sleep defined in reference to polysomnography.
  • The glycemia levels on 24h with a glycemic holter. The parameters of the sympathic system activation evaluated in reference to the measure of the baroreflex sensibility during the awake period.
Read the detailed description

It is a prospective monocentric study after a preliminary period of depistage of the sleep abnormalities by oximetry at home. The patient would be hospitalized for two consecutive days (J0, J1). And the following evaluations will be done:

  • Nocturnal oxymetric + Epworth questionnaire + clinical questionnaire to detect sleep perturbations at home.
  • Blood pressure + heart rate measure
  • Ambulatory blood pressure monitoring on 24 hours
  • Polysomnographic measurements during the J0-J1 night spend at the hospital.
  • Questionnaire of sleep quality and of quality of life.
  • Glycemic measurements on 24h (J0-J1).
  • Measure of the baroreflex sensibility during the awake period at J1.
  • Electrocardiogram
  • Biological examinations (blood and urinary).
Conditions
Type 1 Diabetes
Being tested
Biological examinations (blood and urinary).
Keywords
diapasom, sleep quality, type I diabete, blood pressure, plasma glucose, daytime and nighttime variations
Medical subject headings
Diabetes Mellitus, Type 1, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biological examinations (blood and urinary).Biological

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Polysomnographic measurements during the D0-D1 night spend at the hospital

    Measured: inclusion visit

  2. Ambulatory blood pressure monitoring on 24 hours

    Measured: inclusion visit

Secondary outcomes (1)

  1. Glycemic measurements on 24h (D0-D1).

    Measured: inclusion visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2008 (estimated)
  2. Study startOct 2005
  3. Primary completionDec 2007
  4. Study completionDec 2007

Why it stopped: difficulties for including diabetic patients

Resources

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
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00805974
Sponsor's protocol ID
0513
Other IDs
2005/0479
Acronym
DIAPASOM
Status last verified
Jan 2009
First submitted
9 Dec 2008
Last updated
14 Jan 2009
Results posted
No
Data monitoring committee
No

Publications

  • Borel AL, Benhamou PY, Baguet JP, Halimi S, Levy P, Mallion JM, Pepin JL. High prevalence of obstructive sleep apnoea syndrome in a Type 1 diabetic adult population: a pilot study. Diabet Med. 2010 Nov;27(11):1328-9. doi: 10.1111/j.1464-5491.2010.03096.x. No abstract available.

    PubMed 20950392

Questions about this trial

What is this clinical trial studying?

A study testing Biological examinations (blood and urinary). in people with Type 1 Diabetes, run by University Hospital, Grenoble 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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 14 Jan 2009. 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. 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 was stopped early (reason given: difficulties for including diabetic patients). Results are not available in the source record.

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?

Polysomnographic measurements during the D0-D1 night spend at the hospital (time frame: inclusion visit). The study lists 2 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 NCT00805974, which also lists 1 linked publication.

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 14 Jan 2009.

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