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Completed

NCT Number: NCT02953587

Effect of Ghrelin on Glucose Metabolism After Bariatric Surgery

The purpose of this study is to determine if the altered nutrient exposure to the GI tract after bariatric surgery reveals a negative incretin effect of ghrelin.

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Key information

Conditions

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

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI ≥ 35 kg/m2
  • Age 21-65 years
  • Weight ≤ 200 kg

Exclusion criteria

  • Type 2 or Type 1 diabetes
  • Medications that alter insulin sensitivity or carbohydrate metabolism
  • Positive pregnancy test
  • Known history of intestinal diseases including, but not limited to, inflammatory bowel disease (e.g. Chronic Ulcerative Colitis, Crohn's disease, celiac sprue)
  • Prior gastric or intestinal surgery or pancreas resection
  • History of cardiovascular disease, including but not limited to: myocardial infarction, angioplasty, arrhythmia, uncontrolled hypertension
  • History of chronic kidney disease or renal insufficiency; creatinine > 1.8 mg/dl.
  • History of chronic liver disease, including but not limited to: cirrhosis, hepatitis, portal hypertension; AST and/or ALT > 2x the upper limit of normal.
  • Abnormal ECG

Treatment and study plan

Oral Glucose Tolerance Test (OGTT)

Procedure

Subjects will have glucose administered enterally and blood will be drawn to measure its kinetics.

Other names: OGTT

human ghrelin

Drug

Human ghrelin will be administered by IV at two of the four study visits in conjunction with the OGTT.

Other names: Ghrelin

Saline

Drug

Saline Infusion will be administered by IV at two of the four study visits in conjunction with the OGTT to serve as a placebo comparator for the human ghrelin infusions.

Other names: NaCl, sodium chloride

Primary outcomes

  1. Change in plasma glucose levels with ghrelin versus saline.

    Time frame: 1 month (before and after surgery)

    The objective for this protocol is to determine if ghrelin infusion worsens glucose tolerance during jejunal administration of glucose and if the response is difference after bariatric surgery (RYGB or VSG).

Secondary outcomes

  1. Plasma insulin levels

    Time frame: 1 month (before and after surgery)

Other outcomes

  1. Plasma Levels of GLP-1

    Time frame: 1 month (before and after surgery)

    Metabolic panel to include plasma levels of GLP-1

  2. Plasma Levels of GIP

    Time frame: 1 month (before and after surgery)

    Metabolic panel to include plasma levels of GIP

  3. Plasma Levels of leptin

    Time frame: 1 month (before and after surgery)

    Metabolic panel to include plasma levels of leptin

  4. Plasma Levels of pancreatic polypeptide

    Time frame: 1 month (before and after surgery)

    Metabolic panel to include plasma levels of pancreatic polypeptide

  5. Plasma Levels of Peptide YY (PYY)

    Time frame: 1 month (before and after surgery)

    Metabolic panel to include plasma levels of PYY

  6. Plasma Levels of C-Peptide

    Time frame: 1 month (before and after surgery)

    Metabolic panel to include plasma levels of C-Peptide

  7. Plasma Levels of glucagon

    Time frame: 1 month (before and after surgery)

    Metabolic panel to include plasma levels of glucagon

  8. Plasma Levels of Cholecystokinin (CCK)

    Time frame: 1 month (before and after surgery)

  9. Plasma Levels of Cholecystokinin Adrenocorticotropic Hormone (ACTH)

    Time frame: 1 month (before and after surgery)

  10. Plasma Levels of Human Growth Hormone (HGH)

    Time frame: 1 month (before and after surgery)

  11. Plasma Levels of Cortisol

    Time frame: 1 month (before and after surgery)

  12. Plasma Levels of insulin-like growth factor 1 (IGF-1)

    Time frame: 1 month (before and after surgery)

  13. Acyl and desacyl ghrelin

    Time frame: 1 month (before and after surgery)

  14. Plasma Levels of Bile Acids

    Time frame: 1 month (before and after surgery)

  15. Plasma Levels of Free Fatty Acids (FFAs)

    Time frame: 1 month (before and after surgery)

  16. Plasma Levels of Triglycerides (TG)

    Time frame: 1 month (before and after surgery)

  17. Performance on Visual Analog Scale for Hunger

    Time frame: 1 month (before and after surgery)

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2023
First posted
Nov 3, 2016
Registry last updated
Feb 8, 2023

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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