Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05272839
Other study ID # DiabetesThai22
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2022
Est. completion date July 2024

Study information

Verified date February 2022
Source Antenna Foundation
Contact Praew Kotruchin, Prof
Phone +6643366869
Email kpraew@kku.ac.th
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Diabetic type II patients would be encouraged to eat what they like within a list of food products with hypoglycemic effect, at a similar dosage and preparation mode than the one in the reference clinical trials. This pilot project will be conducted as a randomized controlled trial with 2 arms over 12 weeks: 1. training patients about hypoglycemic spices and foods alongside their usual anti-diabetic treatment, versus usual anti-diabetic treatment alone. Expected results: Confirmation of the hypothesis that daily consuming spices and foods with hypoglycemic effect to diabetic patients can help better control diabetes.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Hypoglycemic food group
A booklet with 4 common food products, clinically validated against diabetes, with instructions for use will be presented to the diabetic patient. The selected food products have been assessed as anti-diabetic for humans through at least one fair randomized comparative clinical trial, with a follow-up of several weeks or months. While continuing to take his/her standard medication if any, the patient will be encouraged to follow his/her preferences within the established list of foods and spices: he is expected to choose 2 plants from the list and to consume each of them every day during the whole duration of the trial (12weeks).
Control group
The control group will receive only lifestyle and dietary recommendations.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Antenna Foundation Khon Kaen University

References & Publications (1)

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

Outcome

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
See also
  Status Clinical Trial Phase
Withdrawn NCT04569214 - The Efficacy and Safety of PAZ320 on PPG and Insulin Blood Levels in Type II Diabetic Patients Phase 2
Completed NCT02127762 - The Effect of Mindfulness Based Stress Reduction in Patients With Painful Diabetic Peripheral Neuropathy N/A
Completed NCT01698528 - Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration N/A
Completed NCT00985114 - Safety and Efficacy Study of EndoBarrier in Subjects With Type II Diabetes and Obesity N/A
Active, not recruiting NCT05120219 - A Study to Assess the Effect of Food on HR20033 and Pharmacokinetic After Multiple Dose in Healthy Volunteers Phase 1
Completed NCT04893135 - Impact of the Rapid Normalization of Chronic Hyperglycemia and the Practice of Moderate Physical Activity on the "Receptor Activator of Nuclear Factor-kappa B Ligand / Osteoprotégérine (RANKL / OPG) System in Patients Living With Type II Diabetes N/A
Not yet recruiting NCT05108350 - A Study to Assess the Bioequivalence of Fixed Dose Combination of HR20033 Relative to Co-administration of the Individual Components in Healthy Chinese Subjects Phase 1
Completed NCT02586129 - Clinical Trial of YH14755 in Subjects With Dyslipidemia and Type II Diabetes Phase 3
Completed NCT02914743 - Providing Preventive Periodontal Treatment to Hospitalized Patients With Diabetes N/A
Completed NCT04540016 - Mass Balance and Biotransformation of [14C]HSK7653 in Human Phase 1
Completed NCT02429258 - Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin Phase 4
Completed NCT01055223 - Fracture Risk With Thiazolidinediones N/A
Terminated NCT02365233 - Fatty Liver Study in Patients With Type II Diabetes Phase 4
Completed NCT05878587 - Burger Allen Exercises in Knee OA With Type II Diabetes N/A
Completed NCT04768673 - A Study to Investigate the PK and Safety of CKD-393 Phase 1
Not yet recruiting NCT05028140 - Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus Phase 3
Terminated NCT01804777 - Epithelial Sodium Channel (ENaC) as a Novel Mechanism for Hypertension and Volume Expansion in Type 2 Diabetes Early Phase 1
Completed NCT01619332 - Clinical Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEZ763 Phase 1/Phase 2
Active, not recruiting NCT06387433 - Effectiveness of an mHealth Mobile App N/A
Completed NCT01881074 - Periodontal Treatment Response in Type II Diabetic Patients