Type 2 Diabetes MellitusNCT00781495
Determinants of Insulin-induced Weight Gain in Type 2 Diabetes Mellitus
An observational study of Type 2 Diabetes Mellitus and Weight Gain, run by Radboud University Medical Center at 3 sites in Netherlands.
Trial summary
The purpose of this study is to find determinants of insulin-induced weight gain in type 2 diabetes mellitus Primary objective: To find an association between weight gain after start of insulin therapy and physical activity levels. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Weight Gain
- What is being tested?
- Sensewear Bodymedia armband
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 3 sitesNetherlands
- Study dates
- Dec 2008to Dec 2011
- 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: Patients with type 2 diabetes mellitus, selected from the out-patient clinic of the Radboud University Nijmegen Medical Centre and four other non-academic hospitals.
Who may be able to join
- patients with type 2 diabetes mellitus
- age 18-85 years
- Hba1c at baseline < 12.0%
- written informed consent
Who cannot join
- Clinical evidence of psychiatric, renal, cardiovascular or liver or other diseases which may influence study results regarding glucose and weight
- Patients with hormonal disorders which may influence weight (i.e. thyroid diseases), even if properly treated with stable hormonal levels
- Excessive alcohol consumption (>20 g/day), and drug abuse
- Use of thiazolidinedione derivatives (TZDs)
- Pregnancy or intention to become pregnant during the study
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites, 3 recruiting
- Recruiting
Jeroen Bosch Hospital
's-Hertogenbosch, North Brabant, 3400 NL
Paetrick Netten, MD, PhD
Paetrick Netten, MD, PhD
- Recruiting
Jeroen Bosch Hospital
's-Hertogenbosch, North Brabant
Linda Kemink, MD, PhD
Linda Kemink, MD, PhD
- Recruiting
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500 HB
Henry Jansen, M
Henry Jansen, MD
About this study
The purpose of this study is to find determinants of insulin-induced weight gain in type 2 diabetes mellitus
Primary objective: To find an association between weight gain after start of insulin therapy and physical activity levels.
Read the detailed description
Insulin therapy is frequently needed to achieve adequate glycaemic control in type 2 diabetes mellitus (T2DM), but often at the expense of weight gain. Insulin-induced weight gain is obviously undesirable in an already overweight population and may negatively affect blood pressure, lipid levels, inflammatory and fibrinolytic parameters, adipocytokines and also deter further optimization of insulin therapy. It is unknown what determinants predict insulin-induced weight gain in type 2 diabetes mellitus.
The aim of this study therefore, is to assess determinants of insulin-induced weight gain in type 2 diabetes mellitus. In a retrospective and cross-sectional study (Jansen HJ et al., submitted) two extreme subgroups were identified (subjects with a weight gain above 80th percentile) and subgroup non-weight gainers (subjects with a weight gain below the 20th percentile). It was found that the gainers had less energy expenditure after initiation of insulin therapy than non-weight gainers. Therefore, the primary aim of this study is to detect an association between energy expenditure and weight gain
- Conditions
- Type 2 Diabetes Mellitus, Weight Gain
- Being tested
- Sensewear Bodymedia armband
- Keywords
- insulin
- Medical subject headings
- Diabetes Mellitus, Type 2, Weight Gain, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensewear Bodymedia armbandDevice
Also called Sensewear Bodymedia system
To assess physical activity levels patients will wear Sensewear bodymedia armband
| Study group | Role | What they receive |
|---|---|---|
| type 2 diabetes mellitus | Not described Receives: Device: Sensewear Bodymedia armband |
What is being measured
The primary outcome is the main question the study is designed to answer.
To detect an association between insulin-induced weight gain and physical activity levels
Measured: 1 year
Secondary outcomes (1)
To assess the relationship between insulin-induced weight gain and cardiovascular risk profile
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
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 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Henry Jansen, MD, Principal investigator, Radboud University Medical CenterCees Tack, Prof.dr., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781495
- Sponsor's protocol ID
- T2DM_insulin_weight gain
- Status last verified
- Sep 2009
- First submitted
- 28 Oct 2008
- Last updated
- 12 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Jansen HJ, Stienstra R, van Diepen JA, Hijmans A, van der Laak JA, Vervoort GM, Tack CJ. Start of insulin therapy in patients with type 2 diabetes mellitus promotes the influx of macrophages into subcutaneous adipose tissue. Diabetologia. 2013 Dec;56(12):2573-81. doi: 10.1007/s00125-013-3018-6. Epub 2013 Sep 25.
PubMed 24065152
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Insulin-induced Weight Gain in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00781495
- Acronym / sponsor ID
- T2DM_insulin_weight gain
- Conditions
- Type 2 Diabetes Mellitus, Weight Gain
- Keywords
- insulin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 29 Oct 2008 (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 find determinants of insulin-induced weight gain in type 2 diabetes mellitus
Primary objective: To find an association between weight gain after start of insulin therapy and physical activity levels.
Detailed description
Insulin therapy is frequently needed to achieve adequate glycaemic control in type 2 diabetes mellitus (T2DM), but often at the expense of weight gain. Insulin-induced weight gain is obviously undesirable in an already overweight population and may negatively affect blood pressure, lipid levels, inflammatory and fibrinolytic parameters, adipocytokines and also deter further optimization of insulin therapy. It is unknown what determinants predict insulin-induced weight gain in type 2 diabetes mellitus.
The aim of this study therefore, is to assess determinants of insulin-induced weight gain in type 2 diabetes mellitus. In a retrospective and cross-sectional study (Jansen HJ et al., submitted) two extreme subgroups were identified (subjects with a weight gain above 80th percentile) and subgroup non-weight gainers (subjects with a weight gain below the 20th percentile). It was found that the gainers had less energy expenditure after initiation of insulin therapy than non-weight gainers. Therefore, the primary aim of this study is to detect an association between energy expenditure and weight gain
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| type 2 diabetes mellitus | – | Device: Sensewear Bodymedia armband |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes mellitus, selected from the out-patient clinic of the Radboud University Nijmegen Medical Centre and four other non-academic hospitals.
Key inclusion criteria (4 listed)
- patients with type 2 diabetes mellitus
- age 18-85 years
- Hba1c at baseline < 12.0%
- written informed consent
Key exclusion criteria (5 listed)
- Clinical evidence of psychiatric, renal, cardiovascular or liver or other diseases which may influence study results regarding glucose and weight
- Patients with hormonal disorders which may influence weight (i.e. thyroid diseases), even if properly treated with stable hormonal levels
- Excessive alcohol consumption (>20 g/day), and drug abuse
- Use of thiazolidinedione derivatives (TZDs)
- Pregnancy or intention to become pregnant during the study
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 |
|---|---|---|
| Sensewear Bodymedia armbandAlso: Sensewear Bodymedia systemTo assess physical activity levels patients will wear Sensewear bodymedia armband | Device | type 2 diabetes mellitus |
Primary outcome
To detect an association between insulin-induced weight gain and physical activity levels
Time frame: 1 year
1 secondary outcome
To assess the relationship between insulin-induced weight gain and cardiovascular risk profile
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2011.
- Derived from this study: PubMed 24065152Jansen HJ, Stienstra R, van Diepen JA, Hijmans A, van der Laak JA, Vervoort GM, Tack CJ. Start of insulin therapy in patients with type 2 diabetes mellitus promotes the influx of macrophages into subcutaneous adipose tissue. Diabetologia. 2013 Dec;56(12):2573-81. doi: 10.1007/s00125-013-3018-6. Epub 2013 Sep 25.
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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.
Henry Jansen, MD principal investigator
Radboud University Medical Center
Cees Tack, Prof.dr. principal investigator
Radboud University Medical Center
3 sites 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 Mellitus and Weight Gain, run by Radboud University Medical Center at 3 sites in Netherlands.
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 5 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 12 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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?
Contact Henry Jansen, MD (0031243611111, h.jansen@aig.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To detect an association between insulin-induced weight gain and physical activity levels (time frame: 1 year). 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 NCT00781495, 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 12 Jul 2011.