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Mechanisms of Diabetes Control After Weight Loss Surgery, Sub-study #1

Mechanisms of Diabetes Control After Weight Loss Surgery, Sub-study #1

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01930448
Enrollment
0
Registered
2013-08-29
Start date
2008-09-30
Completion date
2014-09-30
Last updated
2015-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Banding, Gastric Bypass Surgery, Type 2 Diabetes

Keywords

Bariatric, Gastric Bypass, Gastric Banding,, Type 2 Diabetes, Incretins, GLP-1, GIP, Insulin secretion, insulin sensitivity

Brief summary

Gastric bypass (GBP) and laparoscopic adjustable banding (AGB) are common procedures that can result in significant weight loss and significantly improve type 2 diabetes in 40-80% of cases. The mechanism and time course of these changes have not been well studied and are poorly understood. The primary aim of this study is to investigate the potential weight-independent mechanisms of diabetes remission after GBP, by comparing GBP and AGB subjects after similar weight loss.

Detailed description

All participants will be tested before and then after 10 and 20-30% weight loss after either GBP or AGB surgery. Subjects will undergo an oral glucose tolerance test (OGTT) an isoglycemic intravenous glucose test (IVGT) to assess the incretin effect, a measure of insulin sensitivity by an intravenous insulin sensitivity test (IVGTT) and body composition measurements.

Interventions

None listed

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
St. Luke's-Roosevelt Hospital Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* obese type 2 diabetes individuals scheduled to undergo bariatric surgery by either gastric banding or gastric bypass surgery

Design outcomes

Primary

MeasureTime frameDescription
Change in Incretin EffectBefore surgery, 1, 12, and 24 months postEffect of GBP and AGB on incretin hormones glucagon-like peptide-1 (GLP-1) and gastric inhibitory peptide (GIP)

Secondary

MeasureTime frameDescription
Change in Body CompositionBefore surgery, 12, and 24 months postBody composition measurements to determine body volume, size, and fat

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026