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The Role of the Duodenum in the Pathogenesis of Insulin Resistance and Type 2 Diabetes Mellitus

NCT ID: NCT00568620

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Insulin Resistance and Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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1: Nasogastric feeding tube

Group Type EXPERIMENTAL

Placement of nasogastric feeding tube

Intervention Type PROCEDURE

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

2: Placement of nasojejunal feeding tube

Group Type EXPERIMENTAL

Nasojejunal feeding tube

Intervention Type PROCEDURE

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

Interventions

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Placement of nasogastric feeding tube

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

Intervention Type PROCEDURE

Nasojejunal feeding tube

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Fasting plasma glucose (FPG) \< 100
2. Age 18 to 55
3. BMI 18.5 to 24.9 kg/m2
4. Stable weight for prior 3 months


1. Based on American Diabetes Association criteria of FPG \> 100 and \<126
2. Age 18 to 55
3. BMI 35 to 60 kg/m2
4. Stable weight for prior 3 months


1. Diagnosis of type 2 diabetes mellitus (T2DM) for \< 5 years
2. Hemoglobin A1c \< 8%
3. Age 18 to 55
4. BMI 35 to 60 kg/m2
5. Stable weight for prior 3 months

Exclusion Criteria

1. Use of any of the following medications: Thiazolidinediones, dipeptidyl-peptidase IV (DPP-IV) inhibitors (e.g., sitagliptin), GLP-1 analogs (e.g., exenatide).
2. 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.
3. 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Naji Abumrad

Chairman, Department of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 27279247 (View on PubMed)

Other Identifiers

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R01DK070860

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCRC #1710

Identifier Type: -

Identifier Source: secondary_id

IRB#070770

Identifier Type: -

Identifier Source: org_study_id