Effects of sitagliptin on gastric emptying in healthy subjects.

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000378426

Enrollment

Registered

2007-07-18

Start date

2007-06-15

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This purpose of this study is to evaluate the effect of sitagliptin on gastric emptying, intragastric meal distribution, postprandial glycaemia and insulinaemia in healthy subjects. Glucagon-like peptide-1 (GLP-1) inhibits gastric emptying, thereby slowing the delivery of nutrients, and their absorption, across the small intestine. The rate of entry of carbohydrate into the small intestine is especially important in patients with diabetes. Sitagliptin is an orally administered inhibitor of dipeptidyl-peptidase-IV (DPP-IV), the enzyme responsible for the degradation of GLP-1. It is hypothesised that sitagliptin will increase the GLP-1 response to, and thereby slow gastric emptying and diminish the glycaemic response to, a carbohydrate-containing meal.

Interventions

sitagliptin 100mg, oral, once daily for 2 days Study is a crossover design with a washout period of 5 - 14 days (dependent on equipment scheduling)

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

Body Mass Index (BMI) 19-25 kg/m2

Exclusion criteria

GI diseaseAlcohol >20g dailyCigarettes >10 per dayPregnant or lactating femalesMedication known to influence GI functionCalculated Creatinine Clearance <60ml/minSubjects exposed to ionising radiation in previous 12 months.

Outcome results