Type II DiabetesNCT00694278
Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes
An observational study of Type II Diabetes, run by Ferzli, George S., M.D. F.A.C.S. at 1 site in United States.
Trial summary
The aim of this study and the primary outcome is to clinically evaluate effect of laparoscopic duodenal-jejunal bypass on non-obese type 2 diabetes. Secondary outcomes will evaluate CCK, FFA, Cholesterol Ghrelin, C-peptide, and HbA1c levels. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to not given
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: primary care office
Who may be able to join
- Adults age 20-65 years
- Clinical diagnosis of type II diabetes buy on of the following three criteria (American Diabetes Association)
- A normal or high C-peptide level (to exclude type 1 diabetes) (>.9ng/ml)
- A random plasma glucose of 200mg/dl or more with typical symptom of diabetes
- A fasting plasma glucose of 126mg/dl or more on more than one occasion
- BMI 22-34 KG/m2
Show all 10Show fewer
- Patients on oral hypoglycemic medications or insulin to control T2DM
- Inadequate control of diabetes as defined as HbA1c>7.5
- No contraindication for surgery or General Anesthesia as determined by multidisciplinary surgical team
- Ability to understand and describe the mechanism of action of ricks and benefits of the operation
Who cannot join
- Patients who meet any of the following exclusion criteria will be exclusion criteria will be excluded from enrollment into the study
- Enrolled in another clinical study which involves and investigational drug
- Diagnosis type 1 diabetes
- Pregnancy (all female patients will have beta HCG) or planned pregnancy within 2 years of entry into the study or unwilling to use reliable contraceptive method
- Previous gastric or esophageal surgery
- Immunosuppressive drugs including corticosteroids
- Coagulopathy (INR>1.5 or platelets<50,000/ul)
- Anemia (Hgb<10.0g/dl)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Lutheran Medical Center
Brooklyn, New York, 11220
George Ferzli, MD, 718-630-7351
About this study
Official title: Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes in Adults
The aim of this study and the primary outcome is to clinically evaluate effect of laparoscopic duodenal-jejunal bypass on non-obese type 2 diabetes. Secondary outcomes will evaluate CCK, FFA, Cholesterol Ghrelin, C-peptide, and HbA1c levels. Patients will be followed closely to ensure the desired results are sustained in long term
- Conditions
- Type II Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II DiabetesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ferzli, George S., M.D. F.A.C.S.
- Investigators
- George Ferzli, MD, Study chair, Lutheran Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694278
- Sponsor's protocol ID
- LMC95
- Status last verified
- Jun 2008
- First submitted
- 5 Jun 2008
- Last updated
- 10 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2008. 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 2 Diabetes in Adults
- ClinicalTrials.gov ID
- NCT00694278
- Acronym / sponsor ID
- LMC95
- Conditions
- Type II Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ferzli, George S., M.D. F.A.C.S.
- Study start
- Jun 2008
- First posted
- 10 Jun 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 aim of this study and the primary outcome is to clinically evaluate effect of laparoscopic duodenal-jejunal bypass on non-obese type 2 diabetes. Secondary outcomes will evaluate CCK, FFA, Cholesterol Ghrelin, C-peptide, and HbA1c levels. Patients will be followed closely to ensure the desired results are sustained in long term
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary care office
Key inclusion criteria (10 listed)
- Adults age 20-65 years
- Clinical diagnosis of type II diabetes buy on of the following three criteria (American Diabetes Association)
- BMI 22-34 KG/m2
- Patients on oral hypoglycemic medications or insulin to control T2DM
- Inadequate control of diabetes as defined as HbA1c>7.5
Key exclusion criteria (8 listed)
- Patients who meet any of the following exclusion criteria will be exclusion criteria will be excluded from enrollment into the study
- Enrolled in another clinical study which involves and investigational drug
- Diagnosis type 1 diabetes
- Pregnancy (all female patients will have beta HCG) or planned pregnancy within 2 years of entry into the study or unwilling to use reliable contraceptive method
- Previous gastric or esophageal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2008.
Related trials for Type II Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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 Ferzli, MD study chair
Lutheran Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type II Diabetes, run by Ferzli, George S., M.D. F.A.C.S. at 1 site in United States.
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 10 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 10 Jun 2008. 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 United States. 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 George Ferzli, MD (718-630-7351, gferzli@lmcmc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 10 Jun 2008.