Type 2 Diabetes Clinical Trial
Official title:
Effect of Aqueous Cinnamon Extract on the Postprandial Glycaemia Levels in Type 2 Diabetes Mellitus: a Randomized Controlled Trial
Verified date | November 2021 |
Source | Egas Moniz - Cooperativa de Ensino Superior, CRL |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The type 2 diabetes mellitus is a chronic disease and it is a highly prevalent globally. Cinnamon is a spicy used on the traditional cuisine, which have as been associated with beneficial effects on postprandial blood glucose levels (BGL). The aim of the present study was to investigate the effect of cinnamon tea (6g C. burmannii/100mL) on postprandial glycaemia in type 2 diabetic adults. Following ethical committee approval, thirty-six subjects were selected and randomly allocated in 2 groups (n=18): cinnamon group, which was administrated OGTT (oral glucose tolerance test) followed by cinnamon tea; control group, which was administrated only OGTT. At baseline, anthropometric data, medical condition and pharmacological therapy were collected. A 24-hour dietary recall was taken preceding each intervention. Food Processor SQL (version 10.5.9) program was used to analyze the food nutritional composition. Chemical analysis was performed for total phenols determinations (adapted from Prabha et al) and antioxidant activity for FRAP and for DPPH tests (adapted from K. Thaipong et al.) Statistical analysis was performed using SPSS Statistics program. Data are mean±SEM.
Status | Completed |
Enrollment | 36 |
Est. completion date | October 31, 2016 |
Est. primary completion date | October 3, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 77 Years |
Eligibility | Inclusion Criteria: - subjects aged 18 years or older - subjects with DM2 diagnostic and men or non-pregnant women. Exclusion Criteria: - insulin-treated subjects - history of gastrointestinal symptoms/diseases - allergy to cinnamon - fasting less than 8 hours - cinnamon intake at day before the intervention - intense exercise until 2 hours before the intervention |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Egas Moniz - Cooperativa de Ensino Superior, CRL |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood glucose levels at beginning | Mean values of blood glucose levels from both control and experimental groups | At beginning (before intervention) | |
Primary | Blood glucose levels at 30 minutes | Mean values of blood glucose levels from both control and experimental groups | At 30 minutes after intervention | |
Primary | Blood glucose levels at 60 minutes | Mean values of blood glucose levels from both control and experimental groups | At 60 minutes after intervention | |
Primary | Blood glucose levels at 90 minutes | Mean values of blood glucose levels from both control and experimental groups | At 90 minutes after intervention | |
Primary | Blood glucose levels at 120 minutes | Mean values of blood glucose levels from both control and experimental groups | At 120 minutes after intervention | |
Primary | Incremental area under the curve of blood glucose | Based on the blood glucose values, the blood glucose incremental area under the curve (AUCi) of each participant was defined using the GraphPad Prism program (version 5.0) | At 120 minutes after intervention | |
Primary | Variation of blood glucose maximum concentration | Mean values of glucose maximum concentration variation | At 60 minutes after intervention | |
Secondary | Anthropometric parameters - body weight | Mean values of body weight (in kilogram - Kg) | At baseline | |
Secondary | Anthropometric parameters - height | Mean values of Height (in centimeters - cm) | At baseline | |
Secondary | Anthropometric parameters - waist circumference | Mean values of waist circumference (in centimeters - cm) | At baseline | |
Secondary | Anthropometric parameters - body mass index | Mean values of body mass index (Kg/m2), calculated as weight (Kg) divided by height (m2) squared (Kg/m2) | At baseline | |
Secondary | Anthropometric parameters - Skeletal muscle mass | Mean values of Skeletal muscle mass (in kilogram - Kg) | At baseline | |
Secondary | Anthropometric parameters - visceral fat | Mean values of visceral fat (cm3) | At baseline | |
Secondary | Pharmacological therapy | Percentage of antidiabetic orals (biguanide, sulfonylurea, alpha-glucosidase inhibitor, dipeptidyl peptidase 4 inhibitors | At baseline | |
Secondary | Total protein intake | Means values of total protein intake (in grams - g) obtained through The Food Processor SQL software | At baseline | |
Secondary | Total lipid intake | Means values of total lipid intake (in grams - g) obtained through The Food Processor SQL software | At baseline | |
Secondary | Total carbohydrate intake | Means values of total carbohydrate intake (in grams - g) obtained through The Food Processor SQL software | At baseline | |
Secondary | Total energy intake | Means values of total energy intake (in kilocalorie - Kcal) obtained through The Food Processor SQL software | At baseline | |
Secondary | Total polyphenols content | Mean values of total polyphenols content of cinnamon extract (mg/L equivalent of gallic acid) | At baseline | |
Secondary | Antioxidant activity | Mean values of antioxidant activity of cinnamon extract by FRAP and DPPH assays (micromol Trolox/L) | At baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05219994 -
Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum
|
N/A | |
Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
Completed |
NCT02284893 -
Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
|
Phase 3 | |
Completed |
NCT04274660 -
Evaluation of Diabetes and WELLbeing Programme
|
N/A | |
Active, not recruiting |
NCT05887817 -
Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)
|
Phase 4 | |
Active, not recruiting |
NCT05566847 -
Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Completed |
NCT04965506 -
A Study of IBI362 in Chinese Patients With Type 2 Diabetes
|
Phase 2 | |
Recruiting |
NCT06115265 -
Ketogenic Diet and Diabetes Demonstration Project
|
N/A | |
Active, not recruiting |
NCT03982381 -
SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes
|
Phase 4 | |
Completed |
NCT04971317 -
The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages
|
N/A | |
Completed |
NCT04496154 -
Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood
|
N/A | |
Completed |
NCT04023539 -
Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05530356 -
Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
|
||
Completed |
NCT04097600 -
A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets
|
Phase 1 | |
Completed |
NCT03960424 -
Diabetes Management Program for Hispanic/Latino
|
N/A | |
Completed |
NCT05378282 -
Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
|
||
Active, not recruiting |
NCT06010004 -
A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes
|
Phase 3 | |
Completed |
NCT03653091 -
Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes
|
N/A |