NCT01094054

Brief Summary

The overall aim is to determine the mechanism(s) by which common bariatric surgical procedures alter carbohydrate metabolism. Understanding these mechanisms may ultimately lead to the development of novel interventions for the prevention and treatment of Type 2 diabetes and obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for phase_4 obesity

Timeline
Completed

Started Oct 2010

Typical duration for phase_4 obesity

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

March 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

May 10, 2013

Status Verified

May 1, 2013

Enrollment Period

2.3 years

First QC Date

March 24, 2010

Last Update Submit

May 8, 2013

Conditions

ObesityDiabetes

Outcome Measures

Primary Outcomes (1)

  • Disposition Index

    Insulin sensitivity which measures the overall ability of insulin to stimulate glucose disposal and inhibit glucose production will be calculated from plasma glucose and insulin concentrations using the "oral" glucose minimal model. Beta-cell responsivity indices will be calculated using plasma glucose and C-peptide concentrations using the oral C-peptide minimal model. The appropriateness of insulin secretion for the prevailing degree of insulin action is assessed by calculating the total disposition index (DItotal), which equals the product of insulin secretion and insulin sensitivity.

    Change compared to baseline 12 weeks after intervention

Secondary Outcomes (1)

  • Gastric emptying and intestinal transit

    change compared to baseline 12 weeks after intervention

Study Arms (2)

Dietary and lifestyle modification

ACTIVE COMPARATOR

Patients in this arm will eat meals that are identical in size and caloric composition to those consumed by participants in the other arm who undergo adjustable gastric banding

Behavioral: Dietary and lifestyle modification

Adjustable gastric banding

EXPERIMENTAL

Subjects will undergo gastric banding as per clinical practice

Procedure: Adjustable gastric banding

Interventions

Adjustable gastric bandingPROCEDURE

Placement of adjustable gastric band - laparoscopically

Adjustable gastric banding
Dietary and lifestyle modificationBEHAVIORAL

Dietary and lifestyle modification Subjects will meet with a dietitian and a psychologist on a weekly basis and consume a diet matched to that of the banding arm

Dietary and lifestyle modification

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Subjects less than 30 years of age or who are on insulin will not be studied to minimize the possibility of type 1 diabetes.
  • Subjects older than 65 years of age will not be studied to minimize the potential confounding effects of age on glucose tolerance.
  • Healthy status will indicate that the participant has no known active systemic illness and no history of microvascular or macrovascular complications of their diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Sathananthan M, Shah M, Edens KL, Grothe KB, Piccinini F, Farrugia LP, Micheletto F, Man CD, Cobelli C, Rizza RA, Camilleri M, Vella A. Six and 12 Weeks of Caloric Restriction Increases beta Cell Function and Lowers Fasting and Postprandial Glucose Concentrations in People with Type 2 Diabetes. J Nutr. 2015 Sep;145(9):2046-51. doi: 10.3945/jn.115.210617. Epub 2015 Aug 5.

    PMID: 26246321DERIVED

MeSH Terms

Conditions

ObesityDiabetes Mellitus

Interventions

Diet

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Adrian Vella, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

March 24, 2010

First Posted

March 26, 2010

Study Start

October 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

May 10, 2013

Record last verified: 2013-05

Locations

US(1)