An observational study in Gastric Bypass Surgery and Obesity, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed at 1 site in United States. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-03-09.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Observational
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.
1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.
This study's enrollment of 20 is below the median of 92 across 219 observational studies indexed under Weight Loss.
Browse Weight Loss studies →National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 529 studies on the registry; 54 are open to participants now.
Of its 79 completed or terminated interventional studies of FDA-regulated products, 50 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Morbidly obese patients with type 2 diabetes of less than 5 years duration
Exclusion Criteria:
Surgical group of obese patients with type 2 diabetes undergoing gastric bypass surgery
Procedure: gastric bypass surgery
Diet group of obese patient with type 2 diabetes, matched with the surgical group for diabetes duration, diabetes control (HbA1C), BMI, age.
Other: Diet induced weight loss
weight loss bariatric surgery
low calorie diet with meal replacements. weekly outpatient visits with nutritionist.
Change in incretin
Change in incretin (gastric inhibitory peptide \[GIP\] and glucagon-like peptide-1 \[GLP-1\])
Time frame: One month
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)