Diabetes Mellitus, Type 2GLUCOSTRESSNCT02368704
Role of Endoplasmic Reticulum Stress in the Pathophysiology of Type 2 Diabetes
An observational study of Diabetes Mellitus, Type 2 and Endoplasmic Reticulum Stress, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to investigate whether Endoplasmic Reticulum (ER) stress pathway is activated in peripheral tissues (adipose tissue) in insulin resistant diabetic patients compared to healthy subjects normoglycemic matched for age and sex an to investigate whether ER stress pathway can be activated in… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Endoplasmic Reticulum Stress
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Nov 2016
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with type 2 diabetes Healthy volunteers Adults
Who may be able to join
- Specific criteria for diabetic patients:
- Having type 2 diabetes for at least 6 months
- HbA1c ≤ 8%
- Treated by lifestyle and dietary rules associated or not to a hypoglycemic therapy (metformin and / or sulfamid) and / or insulin secretors dependent glucose as inhibitors of DPP4 (dipeptidyl peptidase-4): Vildagliptin, Sitagliptin, Saxagliptin
- No modification of hypoglycemic therapy and / or insulin secretors for at least 3 months
- Specific criteria for control subjects:
Show all 17Show fewer
- Nondiabetic subjects (fasting blood glucose <7.0 mmol / l without hypoglycemic treatment).
- The control subjects should be matched to patients for age (± 5 years), sex, and BMI (± 2 kg/m2).
- Common criteria for patients and control subjects:
- Aged 18 to 60 years
- Body Mass Index between 25 and 35 kg/m2
- Accepting the constraints of the protocol and who signed the informed consent
- Systolic blood pressure < 160 mmHg, diastolic blood pressure < 90 mm Hg (with or without antihypertensive treatment)
- Resting heart rate between 55 and 100 beats/min.
- Normal laboratory tests or not clinically significant abnormality for NFS platelets, PT, aPTT, fibrinogen ALT, AST, GGT, Serum electrolytes, urea, creatinine, Uric acid Triglycerides, total cholesterol, HDL cholesterol
- HCG negative blood (for female subjects)
- Affiliated to the Social Security.
Who cannot join
- Current infections or recent infections (<10 days)
- Neoplastic disorders (with the exception of carcinoma in situ of the cervix or cutaneous epithelioma), haematological, cardiovascular, psychiatric, neurological
- Poisoning smoking (>10 cigarettes per day, what ever the duration of intoxication)
- Treatment with insulin or glitazones Pregnancy, Breastfeeding
- Body Mass Index > 35 kg/m2
- Any drug taken for less than 8 days without the inclusion of minor analgesics (aspirin, paracetamol), anti-hypertensive medications, oral hypoglycemic (metformin and sulphonylureas) and insulin secretors dependent glucose as inhibitors of DPP4 (dipeptidyl peptidase-4) and oral contraceptives.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate whether Endoplasmic Reticulum (ER) stress pathway is activated in peripheral tissues (adipose tissue) in insulin resistant diabetic patients compared to healthy subjects normoglycemic matched for age and sex an to investigate whether ER stress pathway can be activated in response to insulin. Indeed, some preliminar on rates studies shows that ER stress pathway is activated by insulin in liver and adipose tissue showing that hyperinsulinemia might help trigger stress path ER.
For this, we propose a case control study of type 2 diabetic patients vs control subjects in which markers of ER stress will be evaluated from abdominal subcutaneous adipose tissue obtained before and after euglycemic hyperinsulinemic. We chose to consider adipose tissue subcutaneous rather than visceral adipose tissue for obvious reasons of lesser invasiveness.
- Being tested
- No intervention
- Keywords
- Endoplasmic Reticulum
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| control | control subjects with :
* Nondiabetic subjects (blood glucose <7.0 mmol/l without hypoglycemic treatment).
* The control subjects should be matched to patients for age (± 5 years), sex, and BMI (± 2 kg/m2). Receives: Other: No intervention | |
| case | Diabetic patients with :
* Having type 2 diabetes for at least 6 months
* HbA1c ≤ 8%
* Treat by lifestyle and dietary rules associated or not to a hypoglycemic therapy (metformin and / or sulfamid) and / or insulin secretors dependent glucose as inhibitors of DPP4 (dipeptidyl peptidase-4): Vildagliptin, Sitagliptin, Saxagliptin
* No modification of hypoglycemic therapy and / or insulin secretors for at least 3 months Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Show an increase in markers of ER stress in fasting patients with type 2 diabetes
Protein expression markers of ER stress pathway BiP / GRP 78, CHOP, ATF4 EDEM and XBP-1
Measured: 2 days
Secondary outcomes (4)
Assess whether insulin induces an increase in markers of ER stress
Insulin sensitivity
Measured: 2 days
Insulin secretion in response to glucose infusion
Measured: 2 days
Insulin secretion in response to arginine infusion
Measured: 2 days
Lipolysis on insulin
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startNov 2012
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368704
- Sponsor's protocol ID
- GLUCOSTRESS P 08 11 22
- Acronym
- GLUCOSTRESS
- Status last verified
- Apr 2016
- First submitted
- 15 Feb 2015
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Endoplasmic Reticulum Stress in the Pathophysiology of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02368704
- Acronym / sponsor ID
- GLUCOSTRESS / GLUCOSTRESS P 08 11 22
- Keywords
- Endoplasmic Reticulum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 23 Feb 2015 (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.
The purpose of this study is to investigate whether Endoplasmic Reticulum (ER) stress pathway is activated in peripheral tissues (adipose tissue) in insulin resistant diabetic patients compared to healthy subjects normoglycemic matched for age and sex an to investigate whether ER stress pathway can be activated in response to insulin. Indeed, some preliminar on rates studies shows that ER stress pathway is activated by insulin in liver and adipose tissue showing that hyperinsulinemia might help trigger stress path ER.
For this, we propose a case control study of type 2 diabetic patients vs control subjects in which markers of ER stress will be evaluated from abdominal subcutaneous adipose tissue obtained before and after euglycemic hyperinsulinemic. We chose to consider adipose tissue subcutaneous rather than visceral adipose tissue for obvious reasons of lesser invasiveness.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | Other: No interventioncontrol subjects with : * Nondiabetic subjects (blood glucose <7.0 mmol/l without hypoglycemic treatment). * The control subjects should be matched to patients for age (± 5 years), sex, and BMI (± 2 kg/m2). |
| case | – | Other: No interventionDiabetic patients with : * Having type 2 diabetes for at least 6 months * HbA1c ≤ 8% * Treat by lifestyle and dietary rules associated or not to a hypoglycemic therapy (metformin and / or sulfamid) and / or insulin secretors dependent glucose as inhibitors of DPP4 (dipeptidyl peptidase-4): Vildagliptin, Sitagliptin, Saxagliptin * No modification of hypoglycemic therapy and / or insulin secretors for at least 3 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with type 2 diabetes Healthy volunteers Adults
Key inclusion criteria (17 listed)
- Specific criteria for diabetic patients:
- Having type 2 diabetes for at least 6 months
- HbA1c ≤ 8%
- Treated by lifestyle and dietary rules associated or not to a hypoglycemic therapy (metformin and / or sulfamid) and / or insulin secretors dependent glucose as inhibitors of DPP4 (dipeptidyl peptidase-4): Vildagliptin, Sitagliptin, Saxagliptin
- No modification of hypoglycemic therapy and / or insulin secretors for at least 3 months
Key exclusion criteria (6 listed)
- Current infections or recent infections (<10 days)
- Neoplastic disorders (with the exception of carcinoma in situ of the cervix or cutaneous epithelioma), haematological, cardiovascular, psychiatric, neurological
- Poisoning smoking (>10 cigarettes per day, what ever the duration of intoxication)
- Treatment with insulin or glitazones Pregnancy, Breastfeeding
- Body Mass Index > 35 kg/m2
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 |
|---|---|---|
| No intervention | Other | case, control |
Primary outcome
Show an increase in markers of ER stress in fasting patients with type 2 diabetes
Time frame: 2 days
Protein expression markers of ER stress pathway BiP / GRP 78, CHOP, ATF4 EDEM and XBP-1
4 secondary outcomes
Assess whether insulin induces an increase in markers of ER stress
Time frame: 2 days
Insulin secretion in response to glucose infusion
Time frame: 2 days
Insulin secretion in response to arginine infusion
Time frame: 2 days
Lipolysis on insulin
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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?
An observational study of Diabetes Mellitus, Type 2 and Endoplasmic Reticulum Stress, run by Assistance Publique - Hôpitaux de Paris 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 17 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Apr 2016. 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?
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?
Show an increase in markers of ER stress in fasting patients with type 2 diabetes (time frame: 2 days). 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 18 Apr 2016.