Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge

This study will compare glucose and simple carbohydrate sensitivity. The hypothesis is that rapid emptying of high-glycemic index foods after Roux-En-Y gastric bypass (RYGB) causes reactive hypoglycemia. It is believed that the controlled release offered by an intact pylorus will be advantageous for long term results in bariatric surgery. This study can provide a scientific rationale, in a short duration of time, for why pylorus sparing surgery, such as the sleeve gastrectomy or duodenal switch, may offer therapeutic advantages, as compared to non-pyloric sparing surgery, namely the gastric bypass.

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Key information

Conditions

Hypoglycemia Body Weight Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lenox Hill Hospital 186 E76th Street, 1st Floor

New York, 10021, United States

About this study

Clinical Trial Objective:

The objective of this clinical trial is to determine whether an intact pylorus prevents reactive hypoglycemia following challenge with liquid glucose preparation and/or solid load made of refined flour product that is a simple carbohydrate.

Clinical Trial Design:

This is a prospective, non-randomized, clinical trial.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The patient is greater than 18 years old;
The patient has a BMI > 35;
Patient meets standards for bariatric surgery;

Exclusion criteria

The patient has an incurable malignant or debilitating disease;
The patient has been diagnosed with a severe eating disorder;
The patient is currently pregnant (pregnancy test required for confirmation for those of child bearing years);
The patient is unable to comply with the study requirements, follow-up schedule, or to give valid informed consent

Treatment and study plan

Primary outcomes

Mean Serum Glucose Levels

Time frame: 30, 60, and 120 minutes at 6, 9, and 12 months post-operatively

Serum glucose levels measured to assess reactive hypoglycemia status
Reactive Hypoglycemia Status

Time frame: 6 months, 9 months, 12 months post-op
Postoperative reactive hypoglycemia was defined as either
- serum glucose <60 mg/dL at least 1 hour after initiation of glucose tolerance testing
- serum glucose decrease ≥100 mg/dL within 1 hour after initiation of glucose tolerance testing

Secondary outcomes

Insulin Resistance

Time frame: 6, 9, and 12 months post-operatively

Measured by levels of post prandial insulin
Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing

Time frame: 6, 9, and 12 months post-op

Subjective symptoms of hypoglycemia during glucose tolerance testing measured by patients' responses to a questionnaire about symptoms of Weakness, Nausea, Hunger, Headache, Dizziness, Diaphoresis graded on a yes/no response

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: Oct 20, 2009
Registry last updated: Apr 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed