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Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery

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ClinicalTrials.gov Identifier: NCT00992901
Recruitment Status : Recruiting
First Posted : October 9, 2009
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date  ICMJE October 7, 2009
First Posted Date  ICMJE October 9, 2009
Last Update Posted Date May 18, 2018
Study Start Date  ICMJE October 2009
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2015)
Gut hormones and neural signaling contribution to insulin secretion rate and glucose tolerance [ Time Frame: Each study of the protocol is conducted up to seven hours with data collected at intervals specific to the individual study procedure. ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 8, 2009)
Gut hormones and neural signaling contribution to insulin secretion rate and glucose tolerance [ Time Frame: each individual will be evaluated with series of metabolic studies within a few months ]
Change History Complete list of historical versions of study NCT00992901 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery
Official Title  ICMJE Hormonal and Neural Control of Insulin Secretion Following Gastric Bypass Surgery
Brief Summary RYGB (roux-en-y gastric bypass) has been reported to reverse type 2 diabetes (T2DM) immediately after surgery before any significant weight loss. In addition, a growing number of patients have been recognized with life-threatening hyperinsulinemic hypoglycemia several years following their surgery. While the mechanisms by which RYGB improves glucose metabolism or alters islet cell function in patients after RYGB are not understood, recent studies suggest that increased secretion of GI hormones, primarily glucagon-like peptide 1 (GLP-1), as well as alteration in neural activity may contribute to enhanced insulin secretion in general, and to a greater extent in patients with hypoglycemia. The proposed research is designed to address the role of RYGB on insulin secretion by evaluating the contribution of stimulatory factors (neural and GI hormone) on islet cell function and the islet cell responsiveness to the physiologic stimulatory factors, in RYGB patients with and without hypoglycemia and non-operated controls.
Detailed Description RYGB (roux-en-y gastric bypass) has been reported to reverse type 2 diabetes (T2DM) immediately after surgery before any significant weight loss. In addition, a growing number of patients have been recognized with life-threatening hyperinsulinemic hypoglycemia several years following their surgery. While the mechanisms by which RYGB improves glucose metabolism or alters islet cell function in patients after RYGB are not understood, recent studies suggest that increased secretion of GI hormones, primarily glucagon-like peptide 1 (GLP-1), as well as alteration in neural activity may contribute to enhanced insulin secretion in general, and to a greater extent in patients with hypoglycemia. The proposed research is designed to address the role of RYGB on insulin secretion by evaluating the contribution of stimulatory factors (neural and GI hormone) on islet cell function and the islet cell responsiveness to the physiologic stimulatory factors, in RYGB patients with and without hypoglycemia and non-operated controls
Study Type  ICMJE Interventional
Study Phase Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Post Bariatricsurgery
  • Hypoglycemia
Intervention  ICMJE
  • Drug: Exendin-(9-39)
    A physiological study to evaluate the role of GLP-1 signaling in glucose tolerance and insulin secretion
    Other Name: No other name for Exendin-(9-39)
  • Drug: Atropine
    A physiological study to evaluate the effect of neural activation on insulin secretion and glucose metabolism
    Other Name: Atropine sulfate
  • Drug: GLP-1 and GIP
    A physiological study to evaluate the beta-cell sensitivity to different doses of exogenous gut hormones
    Other Name: No other names for GLP-1 and GIP.
Study Arms
  • Experimental: Exendin-(9-39)
    To evaluate the role of GLP-1 signaling in glucose tolerance and insulin secretion
    Intervention: Drug: Exendin-(9-39)
  • Experimental: atropine
    To evaluate the effect of neural activation on insulin secretion and glucose metabolism
    Intervention: Drug: Atropine
  • Experimental: GLP-1 and GIP
    to evaluate the beta-cell sensitivity to different doses of exogenous gut hormones
    Intervention: Drug: GLP-1 and GIP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 25, 2013)
160
Original Estimated Enrollment  ICMJE
 (submitted: October 8, 2009)
120
Estimated Study Completion Date July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 at 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 melitis; development of any serious medical or psychiatric illness during recruitment or studies;
  • RYGB patients will also 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE
Contact: Marzieh Salehi, MD MS 210-567-6691 salehi@uthscsa.edu
Contact: Andrea Hansis-Diarte 210-567-6691 hansisdiarte@uthscsa.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00992901
Other Study ID Numbers  ICMJE 18-070H
DK083554 ( Other Grant/Funding Number: NIDDK )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party The University of Texas Health Science Center at San Antonio
Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marzieh Salehi, MD, MS Marzieh Salehi
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP