Diabetes MellitusPhase 1DJBDNCT00487526
Duodenal Jejunal Bypass for Type 2 Diabetes (DJBD)
A Phase 1 study testing duodenal jejunal bypass in people with Diabetes Mellitus, run by Ferzli, George S., M.D. F.A.C.S. at 1 site in Dominican Republic.
Trial summary
Study the effect of Duodenal jejunal bypass on human adults with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- duodenal jejunal bypass
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteDominican Republic
- Study dates
- Jun 2007to not given
- Phase
- Phase 1
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 20-65
- Clinical diagnosis of type 2 diabetes
- Non obese with BMI less than 34.
- Oral agents or insulin to control T2DM.
- Inadequate control of diabetes as defined as HbA1c>/7.5
- Understanding of the mechanisms of action of the treatment
Who cannot join
- Children with type 1 diabetes
- Obese with BMI over 34
- Coagulopathy
- Liver cirrhosis
- Unable to comply with study requirements, follow-up or give valid consent
- Currently pregnant
- Previous upper abdominal surgery
- Inabilty to tolerate general anesthesia
Trial locations and contacts
1 site in 1 country.
Dominican Republic1 site, 1 recruiting
- Recruiting
Center for Advance Medicine Abel Gonzalez
Santo Domingo
Abel Gonzalez, MD, 809 543 79 81, abelcayo@yahoo.com
809 227 22 35
About this study
Official title: Clinical Evaluation of the Effect of Duodenal Jejunal Bypass on Type Two Diabetes in Non Obese Adults
Study the effect of Duodenal jejunal bypass on human adults with type 2 diabetes.
Read the detailed description
Adults non obese ( BMI less than 34 ) will undergo duodenal jejunal bypass. The Outcome measures: Blood Sugar, Insulin,HbA1c, CCK,Gastrin, GIP1and 2, Ghrelin, Cholesterol, Triglycerides,FFA, C-Peptide.
- Conditions
- Diabetes Mellitus
- Being tested
- duodenal jejunal bypass
- Keywords
- Bypass, Duodenal jejunal, type 2 diabetes, non-obese adults
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duodenal jejunal bypassProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
control of type 2 diabetes in non obese adults
Measured: two years
Secondary outcomes (1)
CCK FFA,Cholesterol,Ghrelin,C-peptide,HbA1c,Gastrin,GIP,Triglycerides,Insulin
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2007 (estimated)
- Study startJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ferzli, George S., M.D. F.A.C.S.
- Investigators
- George S Ferzli, MD F.A.C.S, Principal investigator, SUNY Downstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487526
- Sponsor's protocol ID
- AS07006
- Acronym
- DJBD
- Status last verified
- Jul 2007
- First submitted
- 11 Jun 2007
- Last updated
- 11 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Effect of Duodenal Jejunal Bypass on Type Two Diabetes in Non Obese Adults
- ClinicalTrials.gov ID
- NCT00487526
- Acronym / sponsor ID
- DJBD / AS07006
- Conditions
- Diabetes Mellitus
- Keywords
- Bypass, Duodenal jejunal, type 2 diabetes, non-obese adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ferzli, George S., M.D. F.A.C.S.
- Study start
- Jun 2007
- First posted
- 18 Jun 2007 (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.
Study the effect of Duodenal jejunal bypass on human adults with type 2 diabetes.
Detailed description
Adults non obese ( BMI less than 34 ) will undergo duodenal jejunal bypass. The Outcome measures: Blood Sugar, Insulin,HbA1c, CCK,Gastrin, GIP1and 2, Ghrelin, Cholesterol, Triglycerides,FFA, C-Peptide.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults age 20-65
- Clinical diagnosis of type 2 diabetes
- Non obese with BMI less than 34.
- Oral agents or insulin to control T2DM.
- Inadequate control of diabetes as defined as HbA1c>/7.5
Key exclusion criteria (8 listed)
- Children with type 1 diabetes
- Obese with BMI over 34
- Coagulopathy
- Liver cirrhosis
- Unable to comply with study requirements, follow-up or give valid consent
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 |
|---|---|---|
| duodenal jejunal bypass | Procedure or surgery | – |
Primary outcome
control of type 2 diabetes in non obese adults
Time frame: two years
1 secondary outcome
CCK FFA,Cholesterol,Ghrelin,C-peptide,HbA1c,Gastrin,GIP,Triglycerides,Insulin
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2007.
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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.
George S Ferzli, MD F.A.C.S principal investigator
SUNY Downstate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing duodenal jejunal bypass in people with Diabetes Mellitus, run by Ferzli, George S., M.D. F.A.C.S. at 1 site in Dominican Republic.
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 6 inclusion and 8 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 11 Jul 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 Dominican Republic. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 George S Ferzli, MD, F.A.C.S (718-667-8100, GFerzli@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
control of type 2 diabetes in non obese adults (time frame: two years). 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 11 Jul 2007.