A study to investigate safety and optimal dose of Dahlia Extract in people with pre-diabetes or type 2 diabetes.

Not Applicable

Completed

• Conditions: Pre Diabetes; type 2 Diabetes; Metabolic and Endocrine - Diabetes; Alternative and Complementary Medicine - Herbal remedies

• Registration Number: ACTRN12620000095965
• Lead Sponsor: Aroma NZ

Brief Summary

The study found that in people with pre-diabetes or T2DM, the high dose Dahlia extract had no effect on HbA1c or blood glucose levels but it reduced the amount of insulin in the blood, which means it helped to reduce insulin resistance. This is a helpful effect as it may help to prevent people putting on weight and reduce the burden on the pancreas so that it might delay the progression of diabetes, and the need for extra medication and or insulin therapy. No adverse effects were observed.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-04
• Study Completion: 2021-08-10
• Last Update Posted: 6 June 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Males 18 years and over
Pre-diabetes or type 2 diabetes with HbA1c between 45 mmol/mol and 60 mmol/mol
Willing to maintain a stable lifestyle throughout the study

Exclusion Criteria

•Using any diabetes drug other than Metformin
•Previous bariatric surgery
•Pregnancy or breast feeding
•Liver disease or AST/ ALT >3x ULN
•Diabetic nephropathy with an eGFR <60.
•Stage 3 or 4 NYHF heart failure
•Proliferative retinopathy
•Allergy to sports tape
•Any other long-term condition considered inappropriate by principal investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glucose data from the Libre will be analysed to determine area under the curve for glucose over 24 hours, and divided into 3-5 hour postprandial periods for each meal. Data will be extracted and averaged for days 4-7 of each treatment dose to allow for steady state to be reached. [Each timepoint (week 2, 3 and 4) will be analysed relative to the baseline week (week 1). Baseline AUC glucose will be taken as the average of days 4-7 of the first week while participants receiving placebo. ]

Secondary Outcome Measures

Name	Time	Method
A secondary analysis will also be conducted to compare BD vs TDS dosing for AUC over 24 hours. An analysis will also be conducted to compare timing of doses before meals, for AUC over the 5-hour post prandial period following meals where a dose has been given. [Secondary analyses will compare conditions between groups at the same timepoint for each dose. Ie the average of days 4-7 AUC glucose during each dosage regimen. ]