NCT01771185

Brief Summary

Gastric bypass surgery resolves type 2 diabetes mellitus (T2DM) without the need for diabetes therapy in \~80% of patients. Moreover, improvement in insulin sensitivity and glucose homeostasis occurs within days after surgery before significant weight loss is achieved. This observation has led to the notion that bypassing the upper gastrointestinal (GI) tract has specific therapeutic effects on insulin action and glucose metabolism. In fact, both surgical and endoscopic procedures that bypass the upper GI tract are currently being studied in human subjects. Recently, a new surgical technique, duodenal-jejunal bypass surgery (DJBS), has been developed specifically to treat T2DM. Data from preliminary studies have shown that DJBS results in glycemic control in 87% of overweight and obese patients with T2DM.These subjects will undergo metabolic studies at the University Hospital in Sao Paulo before and after their surgical procedure. Washington University investigators will: 1) provide technical support and guidance to the physicians performing the studies in Brazil, 2) process and analyze blood samples obtained from the study at the Washington University Center for Human Nutrition, and 3) be involved in analyzing the data and writing the final manuscripts. The effects of DJBS on the following clinical and metabolic parameters will be evaluated

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2012

Status
unknown

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

Study Start

First participant enrolled

October 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 18, 2013

Status Verified

January 1, 2013

Enrollment Period

1 year

First QC Date

January 14, 2013

Last Update Submit

January 17, 2013

Conditions

Type 2 Diabetes

Keywords

Diabetesmetabolic surgeryinsulin resistance

Outcome Measures

Primary Outcomes (1)

  • Hb A1a

    Primary endpoints- glycemic control

    24 mo

Secondary Outcomes (3)

  • Systolic and diastolic blood pressure control

    24 mo

  • fasting glycemic control

    24 months

  • Lipidic control

    24 months

Study Arms (2)

Best medical treatment

ACTIVE COMPARATOR

Metformin 2 g/day; gliclazide 30 mg

Drug: Best medical treatment (Metformin ; gliclazide)

Duodenal jejunal bypass plus sleeve gastrectomy

ACTIVE COMPARATOR

Duodenal jejunal bypass plus sleeve gastrectomy is a metabolic surgical procedure

Procedure: Duodenal jejunal bypass plus sleeve gastrectomy

Interventions

Duodenal jejunal bypass plus sleeve gastrectomyPROCEDURE

Metabolic Surgery Duodenal jejunal bypass plus sleeve gastrectomy

Duodenal jejunal bypass plus sleeve gastrectomy
Best medical treatment (Metformin ; gliclazide)DRUG

Metformin 2 g/day; gliclazide 30 mg

Best medical treatment

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Uncontrolled diabetes ( A1c\>8%)
  • Less than 10 years of history
  • Not taking insulin
  • Ages between 20 and 65 years old
  • BMI between 26-34

You may not qualify if:

  • previous abdominal surgery
  • LADA
  • Using insulin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusInsulin Resistance

Interventions

MetforminGliclazide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsBenzenesulfonamidesSulfonamidesAmidesSulfonylurea CompoundsUreaBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor of Surgery

Study Record Dates

First Submitted

January 14, 2013

First Posted

January 18, 2013

Study Start

October 1, 2012

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

January 18, 2013

Record last verified: 2013-01