Diabetes Mellitus Typ 2 and ObesityNCT01708096
Mechanisms Behind Antidiabetic Effects by Gastric By-pass
A study testing Modifast and Normal diet in people with Diabetes Mellitus Typ 2 and Obesity, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
The aim of the study is to develop new strategies in treatment of continuous increasing number of patients with type 2 diabetes by understanding how bariatric surgery cures or improves this condition. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus Typ 2 and Obesity
- What is being tested?
- Modifast and Normal diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesSweden
- Study dates
- Oct 2009to Nov 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes typ 2
- 18-70 years
- BMI > 35 kg/m2
- Treated with oral antidiabetic agents and/or insulin
- laparoscopic surgery
Who cannot join
- Pharmacological treatment (other then above) witch could affect glucose metabolism
- open surgery
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Karolinska Institutet
Stockholm, Stockholm County Council, 116 91
Uppsala University Hospital
Uppsala
About this study
The aim of the study is to develop new strategies in treatment of continuous increasing number of patients with type 2 diabetes by understanding how bariatric surgery cures or improves this condition.
- Conditions
- Diabetes Mellitus Typ 2 and Obesity
- Being tested
- Modifast, Normal diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModifastDietary supplement
2 weeks before gastric by-pass patients are treated with VLD, 1000 kcal/day
Normal dietDietary supplement
normal diet 2 weeks before gastric by-pass
| Study group | Role | What they receive |
|---|---|---|
| Modifast | Active comparator | treated with VLD Modifast 1000 kcal/day in 2 weeks before gastric by-pass, Receives: Dietary Supplement: Modifast |
| Normal diet | Placebo comparator | normal diet 2 weeks before gastric by-pass surgery Receives: Dietary Supplement: Normal diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Insulin sensitivity measured by hyperinsulinemic normoglycemic clamp technique
Measured: 12-18 month after gastric bypass
Secondary outcomes (1)
Weight reduction
Measured: 12-18 month after gastric bypass
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startOct 2009
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Typ 2 and ObesityStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital
- Responsible party
- Principal investigator, Anders Thorell, Karolinska Institutet
- Investigators
- Anders Thorell, Assoc Prof, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708096
- Sponsor's protocol ID
- 2009/931-31/2
- Status last verified
- Mar 2014
- First submitted
- 9 Oct 2012
- Last updated
- 12 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Behind Antidiabetic Effects by Gastric By-pass
- ClinicalTrials.gov ID
- NCT01708096
- Acronym / sponsor ID
- 2009/931-31/2
- Conditions
- Diabetes Mellitus Typ 2 and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Uppsala University Hospital
- Study start
- Oct 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 16 Oct 2012 (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 aim of the study is to develop new strategies in treatment of continuous increasing number of patients with type 2 diabetes by understanding how bariatric surgery cures or improves this condition.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modifast | Active comparator | Dietary Supplement: Modifasttreated with VLD Modifast 1000 kcal/day in 2 weeks before gastric by-pass, |
| Normal diet | Placebo comparator | Dietary Supplement: Normal dietnormal diet 2 weeks before gastric by-pass surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diabetes typ 2
- 18-70 years
- BMI > 35 kg/m2
- Treated with oral antidiabetic agents and/or insulin
- laparoscopic surgery
Key exclusion criteria (2 listed)
- Pharmacological treatment (other then above) witch could affect glucose metabolism
- open surgery
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 |
|---|---|---|
| Modifast2 weeks before gastric by-pass patients are treated with VLD, 1000 kcal/day | Dietary supplement | Modifast |
| Normal dietnormal diet 2 weeks before gastric by-pass | Dietary supplement | Normal diet |
Primary outcome
Insulin sensitivity
Time frame: 12-18 month after gastric bypass
Insulin sensitivity measured by hyperinsulinemic normoglycemic clamp technique
1 secondary outcome
Weight reduction
Time frame: 12-18 month after gastric bypass
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 12 Mar 2014.
Related trials for Diabetes Mellitus Typ 2 and Obesity
Recruiting
The eHealth Diabetes Remission Trial
Diabetes Mellitus, Type 2
Not yet recruiting
Multicentric Approval Study Trans-Duodenal Barrier for Typ 2 Diabetes With Obesity
Typ 2 Diabetes, Obesity
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.
Anders Thorell, Assoc Prof principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modifast and Normal diet in people with Diabetes Mellitus Typ 2 and Obesity, run by Karolinska Institutet at 2 sites in Sweden.
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 5 inclusion and 2 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 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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. Some participants in this study may receive a placebo. 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?
Insulin sensitivity (time frame: 12-18 month after gastric bypass). 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 12 Mar 2014.