Glucose Metabolism in the Immediate and Short Term Follow up After Bariatric Surgery (MIDAS)

NeuroTherapia, Inc.

Status and phase

Completed

Phase 1

Conditions

Gastric Bypass

Diabetes

Treatments

Procedure: Mixed Meal Tolerance test, Hyperglycemic clamp

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00488423

8585

Details and patient eligibility

About

MIDAS involves an assessment of glucose levels obtained before and after bariatric surgery. There are two different procedural tests involved; an oral glucose tolerance test (mixed meal) and a hyperglycemic clamp test. Two tests are performed preoperatively and five more are performed postoperatively for a one year period. The associated labwork drawn with the mixed meal and clamp tests are demonstrating changes in glucose, insulin and gut hormone levels.

Full description

Tests performed are the Mixed Meal tolerance test, the Hyperglycemic Clamp test, c-peptide, free fatty acids, adipocyte hormone profile levels.

Enrollment

21 patients

Sex

All

Ages

19 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Negative pregnancy test if female
ADA criteria for diabetes type II
Hematocrit > 35 creatinine < 1.9, AST < 3X upper limit of normal, ALT < 3X upper limit of normal, alkaline phos <3X upper limit of normal
Eligibility for bariatric surgery based on the NIH and clinical criteria
Mentally and legally capable of providing consent

Exclusion criteria

Lactating females
Must not have type I diabetes
Systemic steroids taken within 6 months
Clinically significant heart disease
Recent pulmonary embolism, untreated proliferative retinopathy, renal failure, uncontrolled hypertension, autonomic neuropathy, resting heart rate > 100, neuromuscular or musculoskeletal disease.