Type II Diabetes Clinical Trial
Official title:
Association Between Natural Hypoglycemic Foods and Blood Sugar Level: A Pilot Study
Type 2 diabetes patients often do not reach desired control of glycemia despite guidance on changing lifestyle and diet as well as the use of conventional anti-diabetic medication. Parallely in recent years, an array of comparative clinical studies have demonstrated the anti-diabetic effect of more than 10 common spices and food products. Objectives: to evaluate whether proposing a choice of spices and foods products with hypoglycemic effect to diabetic patients can help better control diabetes.
Status | Not yet recruiting |
Enrollment | 124 |
Est. completion date | July 2024 |
Est. primary completion date | July 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Type 2 diabetes patients with poorly controlled glycemia, i.e. at least one of the following measurements: 1. 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), despite = 3 months usual care (lifestyle + medication if applicable). Exclusion criteria: 1. Severe and unstable complications of diabetes: end-organ damage such as nephropathy, retinopathy, neuropathy, etc... 2. Patients with rapid insulin, 3. Any health condition that requires urgent attention, 4. Patients with a cognitive or sensory impairment that may prevent conducting the interview, 5. HbA1c > 11.5% 6. Pregnant women |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Antenna Foundation | Khon Kaen University |
Willcox ML, Elugbaju C, Al-Anbaki M, Lown M, Graz B. Effectiveness of Medicinal Plants for Glycaemic Control in Type 2 Diabetes: An Overview of Meta-Analyses of Clinical Trials. Front Pharmacol. 2021 Nov 26;12:777561. doi: 10.3389/fphar.2021.777561. eCollection 2021. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decrease of = 0.5mmol/L in FPG | Percentage of patients in each group reaching a decrease of = 0.5mmol/L in FPG over 12 weeks | 12 weeks | |
Primary | Decrease of = 0.5 points of percentage of HbA1c | Percentage of patients in each group reaching a decrease of = 0.5 points of percentage from the baseline value in HbA1c over 12 weeks | 12 weeks | |
Secondary | Mean change of FPG | Mean change of FPG e.g. differences between baseline values and values at 12 weeks | 12 weeks | |
Secondary | Target glycemia | Proportion of patients in each group reaching target glycemia over 12 weeks | 12 weeks | |
Secondary | Weight | Mean change of weight [kg] over 12 weeks | 12 weeks | |
Secondary | Mean change of HbA1c | Mean change of HbA1c e.g. differences between baseline values and values at 12 weeks | 12 weeks | |
Secondary | Blood pressure | Mean change of systolic and diastolic blood pressure [mmHg] over 12 weeks | 12 weeks |
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