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GLP-1 - Regulatory Mechanism of Postprandial Glycemia

L

Ludwig Maximilian University of Munich

Status and phase

Completed
Phase 1

Conditions

Gastric Emptying
Healthy Subjects

Treatments

Drug: Saline
Drug: Exendin(9-39)amide

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

Synthetic GLP-1 lowers postprandial (pp) glycemia by stimulating insulin, inhibiting glucagon, and delaying gastric emptying. However, the effects of the endogenous peptide are largely unknown. Using the specific GLP-1 receptor antagonist exendin(9-39)amide (Ex(9-39)) the investigators recently showed that GLP-1 released during intestinal meal perfusion acts as an incretin hormone and as an enterogastrone. As the relative contributions of these effects to controll postprandial glycemia are unclear, the investigators used Ex(9-39) to investigate the mechanisms of action of GLP-1 after an oral meal in humans.

Full description

Two experiments were performed in random order in 12 healthy subjects. After a 50-min basal period subjects ingested a 412 kcal mixed semisolid meal containing 30g oatmeal, labelled with 99mTc-Sn-colloid. Gastric emptying was measured by high-resolution scintigraphy until 210 min after meal ingestion. Saline (SAL) or Ex(9-39) at 900 pmol/kg/min was intravenously infused during the two experiments. In addition, in 6 of the 12 subjects gastric motility was measured by antroduodenal manometry and gastric barostat. AUC: pp incremental area under the curve. Lag period (LP): time to 10% emptying.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy subject
  • >=18 years of age
  • No medication

Exclusion criteria

  • Acute disease
  • Metabolic disease
  • On medication
  • Pregnancy, breast feeding
  • Gastrointestinal surgery
  • Dyspeptische Symptome (Völlegefühl, Blähungen, abdominelle Schmerzereignisse, Übelkeit, Erbrechen, Sodbrennen)
  • Teilnahme an einer klinischen Studie in den vergangenen 6 Monaten

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

12 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Drug: Saline
Exendin(9-39)
Active Comparator group
Treatment:
Drug: Exendin(9-39)amide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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