MedPath

Comparing whey protein and guar gum preloads in type 2 diabetes

Not Applicable
Completed
Conditions
type 2 diabetes
Metabolic and Endocrine - Diabetes
Registration Number
ACTRN12615001272583
Lead Sponsor
Central Adelaide Local Health Network
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
22
Inclusion Criteria

Male or female patients with a diagnosis of type 2 diabetes by WHO criteria (plasma glucose equal to 7.0 mmol/L fasting, or greater than 11.1 mmol/L two hours after a glucose challenge) or with a history of HbA1c greater than or equal to 6.5%, managed by diet or metformin
* Age 18 – 75 years
*Body mass index (BMI) 20- 40 kg/m2, and weight-stable
*HbA1c greater than equal 6.0% and less than or equal to 7.9% at the time of screening
*Haemoglobin above the lower limit of the normal range (i.e. greater than 135 g/L for men and 115 g/L for women), and ferritin above the lower limit of normal (i.e. greater than 10 mcg/L)

Exclusion Criteria

*Requirement for antidiabetic medications other than metformin
*Significant gastrointestinal symptoms, or history of gastrointestinal disease including known gastroparesis, or surgery (other than appendicectomy or cholecystectomy)
*Intake of greater than 20 g alcohol on a daily basis, or cigarette smoking
*Volunteers who have donated blood in the preceding 3 months
*Current use of medications which are likely to affect gastrointestinal function or appetite (opiates, anticholinergics, levodopa, beta blockers, clonidine, nitrates, tricyclic antidepressants, selective serotonin re-uptake inhibitors, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, cisapride, tegaserod, or erythromycin)
*Females of childbearing age who are pregnant, or lactating , or have inadequate contraception
*Vegetarians

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary outcome of the study will be to compare the differences in the incremental area under the curve (iAUC) for blood glucose between the four treatments. [Venous blood sample will be collected at t= -15, 0, 15, 30, 60, 90, 120, 180, 240 min for the measurements of blood glucose. iAUC will be assessed. ]
Secondary Outcome Measures
NameTimeMethod
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