Type 2 Diabetes Treated With InsulinWeightPumpNCT02791295
Lifestyle Intervention in Type 2 Diabetes
A study testing Diet and physical activity program in people with Type 2 Diabetes Treated With Insulin, run by Icadom at 6 sites in France.
Trial summary
The purpose of the study is to determine whether a personalized lifestyle intervention focused on diet and physical activity reinforcement is effective in avoiding weight gain in the first months following initiation of subcutaneous insulin pump therapy in type-2 diabetic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Treated With Insulin
- What is being tested?
- Diet and physical activity program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 6 sitesFrance
- Study dates
- 4 Oct 2016to 17 Mar 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Type 2 diabetic patients with indication of initiation of insulin pump therapy.
- Patients addressed for the insulin pump follow-up to the home care provider supporting the study.
- Public health care security affiliation.
Who cannot join
- Breastfeeding or pregnant woman.
- Not willing to participate as assessed by the investigator.
- Patient engaged in another clinical trial with exclusion criteria for other protocol.
- Patients unable to ride a training bike.
- Unavailable in the next 6 months.
- Patient without a medical certificate done in the last 12 months by a cardiologist attesting the ability to participate in a physical activity reinforcement program.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Annecy-Genevois Hospital
Annecy, 74370
Pierre Oudot Hospital
Bourgoin, 38302
Métropole Savoie Hospital
Chambéry, 73000
Alpes Léman Hospital
Contamine-sur-Arve, 74130
Grenoble University Hospital
Grenoble, 38043
Marseille European Hospital
Marseille, 13003
About this study
Official title: Diet and Physical Activity Lifestyle Intervention to Prevent Body Weight Gain in Patients With Type 2 Diabetes Starting Insulin Pump Treatment: a Randomized Controlled Trial
The purpose of the study is to determine whether a personalized lifestyle intervention focused on diet and physical activity reinforcement is effective in avoiding weight gain in the first months following initiation of subcutaneous insulin pump therapy in type-2 diabetic patients.
Read the detailed description
Patients with type 2 diabetes using insulin pump therapy are gaining weight within the first months of treatment. This weight gain could counterbalance the metabolic benefice of insulin pump treatment in improving glycemic control and could lead to treatment dropout. Lifestyle intervention aiming at improving physical activity and diet in type 2 diabetes is known to brought body weight reduction and cardiometabolic improvement.
The investigator hypothesized that an intensive, home-based, 6-months diet and physical activity program could prevent the body weight gain associated with insulin pump treatment initiation. The investigator will randomize patients with type 2 diabetes into a "lifestyle intervention" arm or a "usual care" control arm at the time of insulin pump treatment initiation. The primary objective will evaluate body weight change at 6 months after insulin pump treatment initiation. The secondary objectives will evaluate change in glycemic control (HbA1c) and body composition at 6 months. In addition, the retention effect will be assessed on body weight change one year after insulin pump treatment initiation, 6 months after the end of the lifestyle intervention.
- Conditions
- Type 2 Diabetes Treated With Insulin
- Being tested
- Diet and physical activity program
- Keywords
- Type 2 diabetes, lifestyle intervention, insulin pump treatment, body weight, body composition
- Medical subject headings
- Diabetes Mellitus, Type 2, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet and physical activity programOther
A personalized intervention focused on improving diet and increasing physical activity will be implemented at-home with a monthly support by a registered dietician and physical activity educator during 6 months
| Study group | Role | What they receive |
|---|---|---|
| Diet and physical activity program | Experimental | Diet and physical activity program with individual coaching Receives: Other: Diet and physical activity program |
| control | No intervention | standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
The difference in body weight changes between the two groups over a six-month period following initiation of insulin pump treatment.
Measured: 6 months
Secondary outcomes (5)
Glycemic control
The difference in HbA1c changes between the two groups after 6-months of insulin pump treatment initiation.
Measured: 6 months
Body composition
The difference between the two groups in distribution of fat mass and lean mass between the first visit and 6 months after initiation of insulin pump treatment.
Measured: 6 months
Diabetes Treatment Satisfaction
The difference between the two groups of scores of the Diabetes Treatment Satisfaction Questionnaire between the first visit and 6 months after initiation of insulin pump treatment.
Measured: 6 months
Intermediate weight change
The difference in weight changes between the two groups after 3-months of insulin pump treatment initiation.
Measured: 3 months
Retention of weight change
The difference in weight changes between the two groups at 12-months of insulin pump treatment initiation.
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 posted6 Jun 2016 (estimated)
- Study start4 Oct 2016
- Primary completion19 Jan 2021
- Study completion17 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Treated With InsulinStudies 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icadom
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AGIR à Dom
- Responsible party
- Sponsor
- Investigators
- Anne-Laure Borel, MD PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791295
- Sponsor's protocol ID
- 2016-A00481-50
- Acronym
- WeightPump
- Status last verified
- Mar 2021
- First submitted
- 1 Jun 2016
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet and Physical Activity Lifestyle Intervention to Prevent Body Weight Gain in Patients With Type 2 Diabetes Starting Insulin Pump Treatment: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02791295
- Acronym / sponsor ID
- WeightPump / 2016-A00481-50
- Conditions
- Type 2 Diabetes Treated With Insulin
- Keywords
- Type 2 diabetes, lifestyle intervention, insulin pump treatment, body weight, body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- IcadomIndustry (pharma, biotech, devices)
- Collaborators
- AGIR à Dom
- Study start
- 4 Oct 2016 (actual)
- Primary completion
- 19 Jan 2021 (actual)
- Study completion
- 17 Mar 2021 (actual)
- First posted
- 6 Jun 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.
The purpose of the study is to determine whether a personalized lifestyle intervention focused on diet and physical activity reinforcement is effective in avoiding weight gain in the first months following initiation of subcutaneous insulin pump therapy in type-2 diabetic patients.
Detailed description
Patients with type 2 diabetes using insulin pump therapy are gaining weight within the first months of treatment. This weight gain could counterbalance the metabolic benefice of insulin pump treatment in improving glycemic control and could lead to treatment dropout. Lifestyle intervention aiming at improving physical activity and diet in type 2 diabetes is known to brought body weight reduction and cardiometabolic improvement.
The investigator hypothesized that an intensive, home-based, 6-months diet and physical activity program could prevent the body weight gain associated with insulin pump treatment initiation. The investigator will randomize patients with type 2 diabetes into a "lifestyle intervention" arm or a "usual care" control arm at the time of insulin pump treatment initiation. The primary objective will evaluate body weight change at 6 months after insulin pump treatment initiation. The secondary objectives will evaluate change in glycemic control (HbA1c) and body composition at 6 months. In addition, the retention effect will be assessed on body weight change one year after insulin pump treatment initiation, 6 months after the end of the lifestyle intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet and physical activity program | Experimental | Other: Diet and physical activity programDiet and physical activity program with individual coaching |
| control | No intervention | –standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult Type 2 diabetic patients with indication of initiation of insulin pump therapy.
- Patients addressed for the insulin pump follow-up to the home care provider supporting the study.
- Public health care security affiliation.
Key exclusion criteria (6 listed)
- Breastfeeding or pregnant woman.
- Not willing to participate as assessed by the investigator.
- Patient engaged in another clinical trial with exclusion criteria for other protocol.
- Patients unable to ride a training bike.
- Unavailable in the next 6 months.
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 |
|---|---|---|
| Diet and physical activity programA personalized intervention focused on improving diet and increasing physical activity will be implemented at-home with a monthly support by a registered dietician and physical activity educator during 6 months | Other | Diet and physical activity program |
Primary outcome
Weight change
Time frame: 6 months
The difference in body weight changes between the two groups over a six-month period following initiation of insulin pump treatment.
5 secondary outcomes
Glycemic control
Time frame: 6 months
Body composition
Time frame: 6 months
Diabetes Treatment Satisfaction
Time frame: 6 months
Intermediate weight change
Time frame: 3 months
Retention of weight change
Time frame: 1 year
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 19 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Anne-Laure Borel, MD PhD principal investigator
University Hospital, Grenoble
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and physical activity program in people with Type 2 Diabetes Treated With Insulin, run by Icadom at 6 sites 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 3 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: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 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?
Weight change (time frame: 6 months). 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 19 Mar 2021.