NCT00270439

Brief Summary

The purpose of this study is to determine whether laparoscopic removal of the omentum (thin layer of fat inside the abdomen) will significantly improve insulin resistance in patients with non-insulin dependent type 2 diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_1 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 26, 2005

Completed
6 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

September 14, 2009

Status Verified

September 1, 2009

Enrollment Period

1 year

First QC Date

December 22, 2005

Last Update Submit

September 10, 2009

Conditions

Diabetes Mellitus Type 2DyslipidemiaHypercholesterolemiaObesity

Keywords

ObesityOmentectomyDiabetes Mellitus Type 2LaparoscopicDyslipidemia

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity as measured by the minimal model and HOMA score

    one year post procedure

Secondary Outcomes (2)

  • Improvement in dyslipidemia

    One year post procedure

  • Decreased use of oral hypoglycemics

    One year post procedure

Study Arms (1)

single arm

EXPERIMENTAL

Removed omentum of patients with type 2 diabetes

Procedure: removal of omentum

Interventions

removal of omentumPROCEDURE

patients with type 2 diabetes had their omentum removed

Also known as: laparoscopic omentum removal
single arm

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-55
  • BMI 30-50
  • Dyslipidemia
  • Non-insulin dependent Type 2 diabetes Mellitus on oral hypoglycemics only

You may not qualify if:

  • Medicare patients
  • significant hepatic enzyme elevations (more than 50% of upper limits of normal)
  • serum creatinine \>1.5 mg/dl
  • history of ketoacidosis or current metabolic acidosis
  • current use of oral anticoagulants
  • positive pregnancy test (β-human chorionic gonadotrophin) for females
  • intercurrent infections
  • taking drugs that are known to affect carbohydrate or lipid metabolism (e.g. steroids, high dose Niacin, β-adrenergic receptor agonists, but does not include anti-diabetic drugs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (7)

  • Thorne A, Lonnqvist F, Apelman J, Hellers G, Arner P. A pilot study of long-term effects of a novel obesity treatment: omentectomy in connection with adjustable gastric banding. Int J Obes Relat Metab Disord. 2002 Feb;26(2):193-9. doi: 10.1038/sj.ijo.0801871.

    PMID: 11850750BACKGROUND

  • Torquati A, Lutfi R, Abumrad N, Richards WO. Is Roux-en-Y gastric bypass surgery the most effective treatment for type 2 diabetes mellitus in morbidly obese patients? J Gastrointest Surg. 2005 Nov;9(8):1112-6; discussion 1117-8. doi: 10.1016/j.gassur.2005.07.016.

    PMID: 16269382BACKGROUND

  • Hansen, E., et al., Omentectomy Improves Insulin Sensitivity in Skeletal Muscle in vivo. 2005, Abstract Society of University Surgeons.

    BACKGROUND

  • Bergman RN, Finegood DT, Ader M. Assessment of insulin sensitivity in vivo. Endocr Rev. 1985 Winter;6(1):45-86. doi: 10.1210/edrv-6-1-45. No abstract available.

    PMID: 3884329BACKGROUND

  • Bonora E, Kiechl S, Willeit J, Oberhollenzer F, Egger G, Targher G, Alberiche M, Bonadonna RC, Muggeo M. Prevalence of insulin resistance in metabolic disorders: the Bruneck Study. Diabetes. 1998 Oct;47(10):1643-9. doi: 10.2337/diabetes.47.10.1643.

    PMID: 9753305BACKGROUND

  • Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.

    PMID: 3899825BACKGROUND

  • Fabbrini E, Tamboli RA, Magkos F, Marks-Shulman PA, Eckhauser AW, Richards WO, Klein S, Abumrad NN. Surgical removal of omental fat does not improve insulin sensitivity and cardiovascular risk factors in obese adults. Gastroenterology. 2010 Aug;139(2):448-55. doi: 10.1053/j.gastro.2010.04.056. Epub 2010 May 7.

    PMID: 20457158DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2DyslipidemiasHypercholesterolemiaObesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism DisordersHyperlipidemiasOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • William O Richards, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2005

First Posted

December 26, 2005

Study Start

January 1, 2006

Primary Completion

January 1, 2007

Study Completion

March 1, 2007

Last Updated

September 14, 2009

Record last verified: 2009-09

Locations

US(1)