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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT00992901
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Hypoglycemia
  • Post Bariatricsurgery

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Exendin-(9-39) — DRUG
    A physiological study to evaluate the role of GLP-1 signaling in glucose tolerance and insulin secretion
  • Atropine — DRUG
    A physiological study to evaluate the effect of neural activation on insulin secretion and glucose metabolism
  • GLP-1 and GIP — DRUG
    A physiological study to evaluate the beta-cell sensitivity to different doses of exogenous gut hormones

Study Details

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.

Key Dates

Start date
Oct 31, 2009
Status verified
Sep 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Exendin-(9-39)
    To evaluate the role of GLP-1 signaling in glucose tolerance and insulin secretion
  • Experimental: atropine
    To evaluate the effect of neural activation on insulin secretion and glucose metabolism
  • Experimental: GLP-1 and GIP
    to evaluate the beta-cell sensitivity to different doses of exogenous gut hormones

Primary Outcome Measure

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. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
South Texas Veterans Health Care SystemSan AntonioTexas78229
Marzieh Salehi
[email protected]
210-567-6691
Jennifer Foster, MSN
[email protected]
210-450-8696
Marzieh Salehi, MD, MS (PRINCIPAL_INVESTIGATOR)
Texas Diabetes Institute - University Health SystemSan AntonioTexas78207
Jennifer Foster, MSN
[email protected]
210-450-8696
Marzieh Salehi, MD, MS
[email protected]
210-567-6691
Marzieh Salehi (PRINCIPAL_INVESTIGATOR)

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By research site
South Texas Veterans Health Care System· San Antonio, TXTexas Diabetes Institute - University Health System· San Antonio, TX

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