Type 2 DiabetesNCT00159211
Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin
A study testing UMULINE NPH and pioglitazone in people with Type 2 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
In type 2 diabetic patients with poor glycemic control despite maximum "classic" oral treatment, bed time insulin therapy may lead to a parallel increase in abdominal visceral and subcutaneous fat, whereas pioglitazone treatment should lead to a stability (or even a decrease ) in visceral and an increase in… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- UMULINE NPH and pioglitazone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- May 2005to May 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- BMI= 26kg/m2
- Maximal treatment with metformin and sulfonylurea
- HbA1c between 7.5 and 9.5%
Who cannot join
- Anterior treatment with glitazones
- Anterior treatment with insulin
- Known heart failure
- Hepatopathy
- Renal filtration less than 60ml/min, Hb<10g/dl
- Corticoids treatment
Trial locations and contacts
1 site in 1 country.
France1 site
Sce de Diabétologie, hôpital de la Pitié-salpêtrière, 83bld de l'hôpital
Paris, 75013
About this study
Official title: Evolution of Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin, in Association With Metformin or Sulfonylurea.
In type 2 diabetic patients with poor glycemic control despite maximum "classic" oral treatment, bed time insulin therapy may lead to a parallel increase in abdominal visceral and subcutaneous fat, whereas pioglitazone treatment should lead to a stability (or even a decrease ) in visceral and an increase in subcutaneous abdominal fat. As visceral fat mass is correlated with insulin-resistance and cardio-vascular risk, the evolution of visceral abdominal fat in type 2 diabetic patients is of great importance.
Main objective:
Read more
To compare visceral and subcutaneous abdominal fat compartment after a six-month bed time insulin or pioglitazone treatment in type 2 diabetic patients with poor glycemic control despite a maximal oral treatment with metformin and sulfonylureas.
The study hypothesis is that quantity of visceral and subcutaneous abdominal adipose tissue should differently evolute comparing a 6 month treatment with pioglitazone® (30 or 45mg/j) or NPH " bed-time " insulin (0.2u/kg/
Read the detailed description
In type 2 diabetic patients with poor glycemic control despite maximum "classic" oral treatment, bed time insulin therapy may lead to a parallel increase in abdominal visceral and subcutaneous fat, whereas pioglitazone treatment should lead to a stability (or even a decrease ) in visceral and an increase in subcutaneous abdominal fat. As visceral fat mass is correlated with insulin-resistance and cardio-vascular risk, the evolution of visceral abdominal fat in type 2 diabetic patients is of great importance.
The study hypothesis is that quantity of visceral and subcutaneous abdominal adipose tissue should differently evolute comparing a 6 month treatment with pioglitazone® (30 or 45mg/j) or NPH " bed-time " insulin (0.2u/kg/
- Conditions
- Type 2 Diabetes
- Being tested
- UMULINE NPH, pioglitazone
- Keywords
- type 2 diabetes
- 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.
UMULINE NPHDrug
UMULINE NPH at bed time with a increasing dose up to get a fasting glycemia under 1.1 g/l
pioglitazoneDrug
30mg daily. After 2 months, if HbA1c has not decreased at least of 1%, the dosage should be increased to 45 mg daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | UMULINE NPH at bed time Receives: Drug: UMULINE NPH |
| 2 | Experimental | pioglitazone 30 mg Receives: Drug: pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal adipose tissue (on scan) variation at 6 month
Measured: 6 months
Secondary outcomes (3)
Cellularity of subcutaneous adipose variation tissue at 6 month
Measured: 6 months
HbA1c, lipid level, adiponectin, CRP variation at 6 month
Measured: 6 months
inflammation gene expression in sub-cutaneous fat
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMay 2005
- Study completionMay 2007
Why it stopped: inclusion was finished
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoires Takeda
- Investigators
- Agnès Hartemann-Heurtier, MDPHD, Principal investigator, Assistance Publique des Hôpitaux de Paris Hôpital Pitié Salpêtrière France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159211
- Sponsor's protocol ID
- P031006
- Status last verified
- Apr 2007
- First submitted
- 7 Sep 2005
- Last updated
- 8 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Hartemann-Heurtier A, Halbron M, Golmard JL, Jacqueminet S, Bastard JP, Rouault C, Ayed A, Pieroni L, Clement K, Grimaldi A. Effects of bed-time insulin versus pioglitazone on abdominal fat accumulation, inflammation and gene expression in adipose tissue in patients with type 2 diabetes. Diabetes Res Clin Pract. 2009 Oct;86(1):37-43. doi: 10.1016/j.diabres.2009.06.028. Epub 2009 Aug 15.
PubMed 19683825
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin, in Association With Metformin or Sulfonylurea.
- ClinicalTrials.gov ID
- NCT00159211
- Acronym / sponsor ID
- P031006
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inclusion was finished
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Laboratoires Takeda
- Study start
- May 2005
- Study completion
- May 2007 (actual)
- First posted
- 12 Sep 2005 (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.
In type 2 diabetic patients with poor glycemic control despite maximum "classic" oral treatment, bed time insulin therapy may lead to a parallel increase in abdominal visceral and subcutaneous fat, whereas pioglitazone treatment should lead to a stability (or even a decrease ) in visceral and an increase in subcutaneous abdominal fat. As visceral fat mass is correlated with insulin-resistance and cardio-vascular risk, the evolution of visceral abdominal fat in type 2 diabetic patients is of great importance.
Main objective:
To compare visceral and subcutaneous abdominal fat compartment after a six-month bed time insulin or pioglitazone treatment in type 2 diabetic patients with poor glycemic control despite a maximal oral treatment with metformin and sulfonylureas.
The study hypothesis is that quantity of visceral and subcutaneous abdominal adipose tissue should differently evolute comparing a 6 month treatment with pioglitazone® (30 or 45mg/j) or NPH " bed-time " insulin (0.2u/kg/
Detailed description
In type 2 diabetic patients with poor glycemic control despite maximum "classic" oral treatment, bed time insulin therapy may lead to a parallel increase in abdominal visceral and subcutaneous fat, whereas pioglitazone treatment should lead to a stability (or even a decrease ) in visceral and an increase in subcutaneous abdominal fat. As visceral fat mass is correlated with insulin-resistance and cardio-vascular risk, the evolution of visceral abdominal fat in type 2 diabetic patients is of great importance.
The study hypothesis is that quantity of visceral and subcutaneous abdominal adipose tissue should differently evolute comparing a 6 month treatment with pioglitazone® (30 or 45mg/j) or NPH " bed-time " insulin (0.2u/kg/
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: UMULINE NPHUMULINE NPH at bed time |
| 2 | Experimental | Drug: pioglitazonepioglitazone 30 mg |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes
- BMI= 26kg/m2
- Maximal treatment with metformin and sulfonylurea
- HbA1c between 7.5 and 9.5%
Key exclusion criteria (6 listed)
- Anterior treatment with glitazones
- Anterior treatment with insulin
- Known heart failure
- Hepatopathy
- Renal filtration less than 60ml/min, Hb<10g/dl
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 |
|---|---|---|
| UMULINE NPHUMULINE NPH at bed time with a increasing dose up to get a fasting glycemia under 1.1 g/l | Drug | 1 |
| pioglitazone30mg daily. After 2 months, if HbA1c has not decreased at least of 1%, the dosage should be increased to 45 mg daily | Drug | 2 |
Primary outcome
Abdominal adipose tissue (on scan) variation at 6 month
Time frame: 6 months
3 secondary outcomes
Cellularity of subcutaneous adipose variation tissue at 6 month
Time frame: 6 months
HbA1c, lipid level, adiponectin, CRP variation at 6 month
Time frame: 6 months
inflammation gene expression in sub-cutaneous fat
Time frame: 6 months
Results and safety
The study was stopped early (reason given: inclusion was finished). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2007.
- Derived from this study: PubMed 19683825Hartemann-Heurtier A, Halbron M, Golmard JL, Jacqueminet S, Bastard JP, Rouault C, Ayed A, Pieroni L, Clement K, Grimaldi A. Effects of bed-time insulin versus pioglitazone on abdominal fat accumulation, inflammation and gene expression in adipose tissue in patients with type 2 diabetes. Diabetes Res Clin Pract. 2009 Oct;86(1):37-43. doi: 10.1016/j.diabres.2009.06.028. Epub 2009 Aug 15.
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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.
Agnès Hartemann-Heurtier, MDPHD principal investigator
Assistance Publique des Hôpitaux de Paris Hôpital Pitié Salpêtrière France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UMULINE NPH and pioglitazone in people with Type 2 Diabetes, 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 4 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: stopped early, as of the sponsor's last update on 8 Nov 2007. 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: inclusion was finished). 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?
Abdominal adipose tissue (on scan) variation at 6 month (time frame: 6 months). 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 NCT00159211, 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 8 Nov 2007.