Improving blood sugar control through patients’ choice of evidence-based spices and foods with hypoglycaemic effect – A pragmatic trial.

Not Applicable

• Conditions: Nutritional, Metabolic, Endocrine

• Registration Number: PACTR202202640395224
• Lead Sponsor: Antenna Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-14
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Type 2 diabetes patients with poorly controlled glycaemia, despite =6 months usual care (lifestyle + medication if applicable) + at least one of the following measurements:
- Fasting plasma glucose (FPG) values > 7.0 mmol/L (126 mg/dl),
- or 2-h post-load plasma glucose > 11.1 mmol/L (200 mg/dl),
- or HbA1c > 6.5% (48 mmol/mol);
- or a random blood glucose > 11.1 mmol/L (200 mg/ dl) .
- If under medication, it has been remaining the same treatment and dosage for at least 3 months -- and it is planned to keep this treatment the same for the next 3 months

Exclusion Criteria

- All severe complications of diabetes: end-organ damage such as nephropathy, retinopathy, neuropathy, etc...
- Any health condition that requires urgent attention
- Patients with a cognitive or sensory impairment that may prevent conducting the interview

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Percentage of patients in each group reaching a decrease of = 0.5mmol/L in FPG<br>- Percentage of patients reaching a decrease of = 0.5 points of percentage from the baseline value in HbA1c; each of these reductions being deemed as clinically significant.<br>

Secondary Outcome Measures

Name	Time	Method
-Mean reduction of FPG and mean reduction of HbA1c e.g. differences between baseline values and values at 3 months;<br>-Proportion of patient in each group reaching target glycaemia (<7mmol/L for FPG and <6,5% for HbA1c);<br>-Mean change of weight and mean change of blood pressure e.g. differences between baseline values and values at 3 months;<br>-Proportion of patients who wish to continue to take the plant after the intervention;<br>-Assessment of adverse effects.