Current partner codePEPTIDESDE
NCT02823665·Early Phase 1·INTERVENTIONAL

The Effects of Bariatric Surgeries on Glucose Metabolism

Status

Recruiting

Phase

Early Phase 1

Enrollment

200

Locations

2

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The purpose of this study is learn the effect of gastric bypass surgery and sleeve gastrectomy on glucose metabolism mediated by neural and hormonal factors initiated after eating.

Full detailed description

The purpose of this study is to determine the weight-independent effects of gastric bypass surgery and sleeve gastrectomy surgery on islet cell response after meal ingestion as mediated by hormonal and neural components of the gut. It will also address the differences between the two procedures. Such information will be critical for the development of novel approaches for treatment of diabetes as well as improvement of glycemic effects of gastric bypass and sleeve gastrectomy in patients with partial diabetes remission or relapse after complete remission.

Interventions

Treatment arms and agents.

DRUG

Exendin-(9-39)

A physiological study to evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion.

DRUG

Atropine

A physiological study to evaluate the effect of neural activation on insulin secretion and glucose metabolism.

Timeline

From registration to results.

  1. First posted

    Jul 6, 2016

  2. Study start

    Jul 2015

  3. Primary completion

    Aug 2026

  4. Study completion

    Aug 2027

  5. Results posted

    Not reported

  6. Registry updated

    Sep 9, 2025

Outcomes

What the study measures.

Primary outcomes

Insulin levels measured after nutrient ingestion

Time frame · Each study in the protocol is conducted up to seven hours with data collected at intervals specific to the individual study procedure.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
Yes

Inclusion Criteria: * Hypoglycemic RYGB patients with documented blood glucose level \<50 mg/dl * Asymptomatic individuals with bariatric surgery * Healthy non-surgical patients with no personal history of diabetes * Subjects must physically be able to come to our clinical research center Cedars-Sinai Medical Center Exclusion Criteria: * Active heart, lung, liver, gastrointestinal or kidney disease; unable to give informed consent; pregnancy; uncontrolled high blood pressure or high cholesterol; significant anemia (hemoglobin \<11g/dL); prisoners or institutionalized individuals; type 2 diabetes mellitis; development of any serious medical or psychiatric illness during recruitment or studies; * RYGB patients will be disqualified if they have gastric outlet obstruction or severe diarrhea. * Healthy non-surgical patients with personal history of diabetes For administration of atropine, the following exclusions also apply: * History of glaucoma * Uncontrolled hypertension (any subjects with BP\>140/90 and history of dyslipidemia * Taking any medication that might interact with atropine and cannot be stopped will be excluded from the study) * Myasthenia gravis * Brain pathology * Enlarged prostate in men

Study locations

2 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Texas Diabetes Institute - University Health System

San Antonio, Texas, United States

South Texas Veterans Health Care System

San Antonio, Texas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Secretin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.