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NCT01083108 · ClinicalTrials.gov registry record · Phase 2

Effects of Caloric Restriction Alone Versus Postoperative Caloric Restriction Following Bariatric Surgery on Glucose Metabolism in Patients With Diabetes Mellitus

A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Terminated
Registry status
Phase 2
Development phase
5
Enrollment target

NCT01083108: Clinical Trial Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

NCT01083108 is a Phase 2 study that was terminated before completion, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01083108, a Phase 2 study, was terminated before completion, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

TERMINATED
Registry status
Phase 2
Development phase
5 participants
Enrollment target

Study Summary

Background: * Bariatric surgery is the most effective way to achieve significant, long-term weight loss. It has also been shown to be an effective therapy for obese individuals with type 2 diabetes: more than 70 percent of patients no longer need medications for diabetes after surgery. This resolution of diabetes is predominately caused by marked weight loss resulting in improved insulin sensitivity. However, the beneficial effects of bariatric surgery on type 2 diabetes cannot be accounted for entirely by weight loss, because many bariatric surgery patients have resolution of diabetes within 1 week following bariatric surgery, even before they lose a clinically significant amount of weight. * One possible reason for the rapid resolution of diabetes after bariatric surgery .is that during the first week after surgery, patients can eat very little (about 300 Calories per day). It is well known that reducing calories to this level improves diabetes. Another possibility is that changes in the flow of food through the intestines may improve diabetes. Evidence for this comes from the observation that patients after gastric bypass have better glucose levels than those who have gastric banding. Researchers are interested in determining how much of the improvement in diabetes in the first week after Roux-en-Y gastric bypass (RYGBP) surgery is due to restricting calories, and how much is due to other factors, such as bypassing the upper part of the small intestine. Objectives: * To determine the change in total body insulin sensitivity after RYGBP compared to caloric restriction without surgery. * To study possible reasons for improvements in diabetes after RYGBP. Eligibility: \- Individuals 18 to 60 years of age who have a body mass index (BMI) greater than 35 and have type 2 diabetes. Design: \- This is not a randomized study, and patients will not receive bariatric surgery as part of this study. Two groups of patients will be studied: those scheduled for RYGBP sur

Primary Outcome

Insulin sensitivity will be determined using the gold standard euglycemic hyperinsulinemic clamp method, which directly measures total body insulin sensitivity as the glucose disposal rate, M, during steady state conditions of euglycemia and hyperinsulinemia. A two- stage clamp will be performed, using first a low-dose insulin infusion (to determine hepatic insulin sensitivity), followed by a high-dose insulin infusion (to determine muscle insulin sensitivity).

Interventions

  • OTHER Caloric Restriction
  • OTHER Roux-en-Y Gastric Bypass

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2011-03-31
Est. Completion 2019-12-13
Phase Phase 2

Why NCT01083108 stopped before completion

NCT01083108 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which Caloric Restriction is the first listed.

NCT01083108 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01083108 about?

NCT01083108 is a clinical study titled "Effects of Caloric Restriction Alone Versus Postoperative Caloric Restriction Following Bariatric Surgery on Glucose Metabolism in Patients With Diabetes Mellitus". Background: * Bariatric surgery is the most effective way to achieve significant, long-term weight loss. It has also been shown to be an effective therapy for obese individuals with type 2 diabetes: more than 70 percent of patients no longer need medications for diabetes after surgery. This resolut...

What is the current status of trial NCT01083108?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2011-03-31. Estimated completion is 2019-12-13.

What interventions are being tested in trial NCT01083108?

The interventions under investigation include: Caloric Restriction (OTHER), Roux-en-Y Gastric Bypass (OTHER).

Who is sponsoring clinical trial NCT01083108?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01083108's enrollment target sits among peer trials

5 2000th of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01083108, the US trial registry maintained by the National Library of Medicine. NCT01083108 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.