Insulin Resistance and Type 2 DiabetesNCT00568620
The Role of the Duodenum in the Pathogenesis of Insulin Resistance and Type 2 Diabetes Mellitus
A study testing Placement of nasogastric feeding tube and Nasojejunal feeding tube in people with Insulin Resistance and Type 2 Diabetes, run by Vanderbilt University.
Trial summary
In parallel with the increasing prevalence of obesity worldwide, type 2 diabetes mellitus (T2DM) has reached epidemic proportions. Despite a multitude of available therapies, only bariatric surgery (e.g., roux-en-Y gastric bypass (GBP)) has proven to be an effective long term treatment modality for morbid obesity. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance and Type 2 Diabetes
- What is being tested?
- Placement of nasogastric feeding tube and Nasojejunal feeding tube
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Sep 2016
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fasting plasma glucose (FPG) < 100
- Age 18 to 55
- BMI 18.5 to 24.9 kg/m2
- Stable weight for prior 3 months
- Based on American Diabetes Association criteria of FPG > 100 and <126
- Age 18 to 55
Show all 13Show fewer
- BMI 35 to 60 kg/m2
- Stable weight for prior 3 months
- Diagnosis of type 2 diabetes mellitus (T2DM) for < 5 years
- Hemoglobin A1c < 8%
- Age 18 to 55
- BMI 35 to 60 kg/m2
- Stable weight for prior 3 months
Who cannot join
- Use of any of the following medications: Thiazolidinediones, dipeptidyl-peptidase IV (DPP-IV) inhibitors (e.g., sitagliptin), GLP-1 analogs (e.g., exenatide).
- Subjects with T2DM who are unable to maintain adequate glycemic control (i.e., having a fasting blood glucose that exceeds 250mg/dL on two consecutive tests) while temporarily discontinuing their oral diabetes medications for the study and in whom the study physician determines insulin therapy would not be appropriate.
- Females with a positive pregnancy test
- 5. Prior gastric, duodenal, proximal jejunal surgery or pancreas resection 6. Known malabsorptive disorder 7. History of cancer in past 5 years 8. Renal insufficiency defined by serum creatinine > 1.5 mg/dl 9. Hepatic enzyme elevations of greater than twice the upper limits of normal 10. Current use of warfarin or clopidogrel 11. Intercurrent infections 12. Contraindication to nasogastric or nasojejunal feeding tube (e.g., deviated nasal septum, prior upper gastrointestinal bleed, or history of easy bleeding) 13. Residence outside the greater Nashville, TN area
About this study
In parallel with the increasing prevalence of obesity worldwide, type 2 diabetes mellitus (T2DM) has reached epidemic proportions. Despite a multitude of available therapies, only bariatric surgery (e.g., roux-en-Y gastric bypass (GBP)) has proven to be an effective long term treatment modality for morbid obesity. Moreover, the majority of T2DM patients who undergo GBP experience normalization of their blood glucose and are able to discontinue their anti-diabetes medications soon after the procedure. The insulin resistant state commonly seen in non-diabetic obese subjects also improves after GBP. Evidence from recent animal studies suggests that the rapid return to euglycemia seen in T2DM patients after GBP might in part result from excluding the duodenum from the flow of nutrients. With the use of enteral feeding tubes, we hope to better understand the factors in the human gut that may predispose obese individuals to the development of insulin resistance and T2DM.
- Conditions
- Insulin Resistance and Type 2 Diabetes
- Being tested
- Placement of nasogastric feeding tube, Nasojejunal feeding tube
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of nasogastric feeding tubeProcedure or surgery
Glucose tolerance test via nasogastric feeding tube
50 g glucose tolerance test on day 1; 50 g glucose tolerance test with 30 mL oil on day 2; Intravenous glucose tolerance test on day 3
Nasojejunal feeding tubeProcedure or surgery
Glucose tolerance test via nasojejunal feeding tube
50 g glucose tolerance test on day 1; 50 g glucose tolerance test with 30 mL oil on day 2; Intravenous glucose tolerance test on day 3
| Study group | Role | What they receive |
|---|---|---|
| 1: Nasogastric feeding tube | Experimental | Not described Receives: Procedure: Placement of nasogastric feeding tube |
| 2: Placement of nasojejunal feeding tube | Experimental | Not described Receives: Procedure: Nasojejunal feeding tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Measured: 3 days
Secondary outcomes (1)
Incretin effect
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study startMay 2008
- Primary completionJun 2012
- Study completionSep 2016
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 Insulin Resistance and Type 2 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naji Abumrad, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568620
- Sponsor's protocol ID
- IRB#070770
- Other IDs
- R01DK070860, GCRC #1710
- Status last verified
- Oct 2016
- First submitted
- 4 Dec 2007
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tamboli RA, Sidani RM, Garcia AE, Antoun J, Isbell JM, Albaugh VL, Abumrad NN. Jejunal administration of glucose enhances acyl ghrelin suppression in obese humans. Am J Physiol Endocrinol Metab. 2016 Jul 1;311(1):E252-9. doi: 10.1152/ajpendo.00082.2016. Epub 2016 Jun 7.
PubMed 27279247
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Duodenum in the Pathogenesis of Insulin Resistance and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00568620
- Acronym / sponsor ID
- IRB#070770
- Conditions
- Insulin Resistance and Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 6 Dec 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.
In parallel with the increasing prevalence of obesity worldwide, type 2 diabetes mellitus (T2DM) has reached epidemic proportions. Despite a multitude of available therapies, only bariatric surgery (e.g., roux-en-Y gastric bypass (GBP)) has proven to be an effective long term treatment modality for morbid obesity. Moreover, the majority of T2DM patients who undergo GBP experience normalization of their blood glucose and are able to discontinue their anti-diabetes medications soon after the procedure. The insulin resistant state commonly seen in non-diabetic obese subjects also improves after GBP. Evidence from recent animal studies suggests that the rapid return to euglycemia seen in T2DM patients after GBP might in part result from excluding the duodenum from the flow of nutrients. With the use of enteral feeding tubes, we hope to better understand the factors in the human gut that may predispose obese individuals to the development of insulin resistance and T2DM.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Nasogastric feeding tube | Experimental | Procedure: Placement of nasogastric feeding tube |
| 2: Placement of nasojejunal feeding tube | Experimental | Procedure: Nasojejunal feeding tube |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Fasting plasma glucose (FPG) < 100
- Age 18 to 55
- BMI 18.5 to 24.9 kg/m2
- Stable weight for prior 3 months
- Based on American Diabetes Association criteria of FPG > 100 and <126
Key exclusion criteria (4 listed)
- Use of any of the following medications: Thiazolidinediones, dipeptidyl-peptidase IV (DPP-IV) inhibitors (e.g., sitagliptin), GLP-1 analogs (e.g., exenatide).
- Subjects with T2DM who are unable to maintain adequate glycemic control (i.e., having a fasting blood glucose that exceeds 250mg/dL on two consecutive tests) while temporarily discontinuing their oral diabetes medications for the study and in whom the study physician determines insulin therapy would not be appropriate.
- Females with a positive pregnancy test
- 5. Prior gastric, duodenal, proximal jejunal surgery or pancreas resection 6. Known malabsorptive disorder 7. History of cancer in past 5 years 8. Renal insufficiency defined by serum creatinine > 1.5 mg/dl 9. Hepatic enzyme elevations of greater than twice the upper limits of normal 10. Current use of warfarin or clopidogrel 11. Intercurrent infections 12. Contraindication to nasogastric or nasojejunal feeding tube (e.g., deviated nasal septum, prior upper gastrointestinal bleed, or history of easy bleeding) 13. Residence outside the greater Nashville, TN area
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 |
|---|---|---|
| Placement of nasogastric feeding tubeGlucose tolerance test via nasogastric feeding tube 50 g glucose tolerance test on day 1; 50 g glucose tolerance test with 30 mL oil on day 2; Intravenous glucose tolerance test on day 3 | Procedure or surgery | 1: Nasogastric feeding tube |
| Nasojejunal feeding tubeGlucose tolerance test via nasojejunal feeding tube 50 g glucose tolerance test on day 1; 50 g glucose tolerance test with 30 mL oil on day 2; Intravenous glucose tolerance test on day 3 | Procedure or surgery | 2: Placement of nasojejunal feeding tube |
Primary outcome
Insulin sensitivity
Time frame: 3 days
1 secondary outcome
Incretin effect
Time frame: 3 days
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 1 Nov 2016.
- Derived from this study: PubMed 27279247Tamboli RA, Sidani RM, Garcia AE, Antoun J, Isbell JM, Albaugh VL, Abumrad NN. Jejunal administration of glucose enhances acyl ghrelin suppression in obese humans. Am J Physiol Endocrinol Metab. 2016 Jul 1;311(1):E252-9. doi: 10.1152/ajpendo.00082.2016. Epub 2016 Jun 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of nasogastric feeding tube and Nasojejunal feeding tube in people with Insulin Resistance and Type 2 Diabetes, run by Vanderbilt University.
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 13 inclusion and 4 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 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Insulin sensitivity (time frame: 3 days). 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 NCT00568620, 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 1 Nov 2016.