A trial to evaluate the effects of different monosaccharide preloads on incretin hormone secretion, gastric emptying and post-meal blood glucose in healthy subjects and patients with type 2 diabetes mellitus.

A randomised placebo controlled crossover trial to evaluate the effects of different monosaccharide preloads on incretin hormone secretion, gastric emptying and postprandial glycaemia in healthy subjects and patients with type 2 diabetes mellitus.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000775910

Enrollment

Registered

2011-07-22

Start date

2010-02-24

Completion date

2010-05-03

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

The study will evaluate the effects of different sugars on the release of the incretin hormone GLP-1 from the small intestine, and how this affects the gastric emptying of, and glycaemic response to, a subsequent meal, in both healthy subjects and patients with type 2 diabetes.

Interventions

Each subject will undergo four studies, in which they will receive a sweet "preload" drink, containing either 40g glucose, 40g 3-O-methylglucose, 40g Tagatesse, or 60mg sucralose (placebo control) in double-blind, randomised fashion, separated by 3 - 7 days, consumed between T=-22 to -20 min, before a mashed potato meal consumed between T=-5 to 0 min.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy volunteers and patients with type 2 diabetes mellitus

Exclusion criteria

Medications affecting gut function; Alcohol intake >20g daily or cigarette smoking; Significant gastrointestinal disease or surgery; Impaired liver or renal function; Blood donation within 3 months

Outcome results