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Mechanisms of Diabetes Control After Weight Loss Surgery

Mechanisms of Diabetes Control After Weight Loss Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00571220
Enrollment
20
Registered
2007-12-11
Start date
2005-09-30
Completion date
2010-12-31
Last updated
2018-03-09

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

Conditions

Gastric Bypass Surgery, Obesity

Keywords

gastric bypass, diabetes, obesity, diet-induced weight loss, incretin levels (GLP-1,GIP), incretin effect

Brief summary

Obesity and type 2 diabetes (T2DM) are increasing in the US. One third of patients seeking bariatric surgery have T2DM. Although all surgeries result in significant weight loss and often 'cure' the T2DM, the rapid onset and the magnitude of the benefits of gastric bypass (GBP) on T2DM has thus far baffled clinical scientists. Limited data suggest that the improvement in T2DM after GBP occurs very rapidly, and may not be wholly accounted for by weight loss. Secretion of incretins (gut peptides secreted in response to meals which enhance insulin secretion) is impaired in T2DM and improves after GBP, possibly due to the specific anatomical changes after this surgery. While some determinants of impaired insulin secretion, such as glucotoxicity, improve equally after diet or surgical weight loss, the improvement in the incretin effect after GBP might be specific to this surgery. The aim of this study is to determine whether the magnitude of the incretin effect on insulin secretion is greater after GBP than after an equivalent diet-induced weight loss. We will compare, in obese patients with diabetes, randomized to very low calorie diet or to GBP, the effect of an equivalent weight loss on the incretin effect (difference in insulin secretion after comparable oral and intravenous (IV) glucose loads). As more obese diabetic patients undergo GBP, understanding the mechanisms that produce improvement in their diabetes is increasingly important.

Interventions

PROCEDUREgastric bypass surgery

weight loss bariatric surgery

OTHERDiet induced weight loss

low calorie diet with meal replacements. weekly outpatient visits with nutritionist.

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead SponsorNIH

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

* morbidly obese with type 2 diabetes candidates and being evaluated at our institution for bariatric surgery (group1); morbidly obese patients with type 2 diabetes who want to lose weight by diet.

Exclusion criteria

* any condition that would be contra-indicated for bariatric surgery (ex:unstable angina) * diabetes treated by insulin, thiazolidinediones (TZD), exenatide, DPP-IV inhibitors * HbA1C \> 8%

Design outcomes

Primary

MeasureTime frameDescription
Change in incretinOne monthChange in incretin (gastric inhibitory peptide \[GIP\] and glucagon-like peptide-1 \[GLP-1\])

Countries

United States

Outcome results

None listed

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