Trial Outcomes & Findings for Effect of Artemisia Dracunculus on Glucose Intolerance, Insulin Sensitivity and Insulin Secretion (NCT NCT02330341)
NCT ID: NCT02330341
Last Updated: 2020-10-08
Results Overview
Postprandial glucose will be evaluated at baseline and week 12 after a oral glucose tolerance test with enzymatic-colorimetric techniques
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Week 12
Results posted on
2020-10-08
Participant Flow
Participant milestones
| Measure |
Artemisia Dracunculus
Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Artemisia dracunculus
|
Placebo
Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Artemisia Dracunculus on Glucose Intolerance, Insulin Sensitivity and Insulin Secretion
Baseline characteristics by cohort
| Measure |
Artemisia Dracunculus
n=12 Participants
Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Artemisia dracunculus
|
Placebo
n=12 Participants
Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Placebo
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.1 years
STANDARD_DEVIATION 7 • n=5 Participants
|
48.5 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
48.3 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Postprandial glucose levels
|
10 mmol/L
STANDARD_DEVIATION 1.3 • n=5 Participants
|
9.7 mmol/L
STANDARD_DEVIATION 1.1 • n=7 Participants
|
9.9 mmol/L
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Fasting glucose levels
|
5.5 mmol/L
STANDARD_DEVIATION 0.8 • n=5 Participants
|
5.9 mmol/L
STANDARD_DEVIATION 0.9 • n=7 Participants
|
5.7 mmol/L
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Glycosylated Hemoglobin
|
5.8 percentage
STANDARD_DEVIATION 0.3 • n=5 Participants
|
5.9 percentage
STANDARD_DEVIATION 0.4 • n=7 Participants
|
5.8 percentage
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
First phase of insulin secretion
|
1057 index
STANDARD_DEVIATION 529 • n=5 Participants
|
1395 index
STANDARD_DEVIATION 1138 • n=7 Participants
|
1226 index
STANDARD_DEVIATION 885 • n=5 Participants
|
|
Total insulin secretion
|
0.5 index
STANDARD_DEVIATION 0.2 • n=5 Participants
|
0.7 index
STANDARD_DEVIATION 0.4 • n=7 Participants
|
0.6 index
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
Insulin sensitivity
|
2.6 index
STANDARD_DEVIATION 1.3 • n=5 Participants
|
1.9 index
STANDARD_DEVIATION 1.2 • n=7 Participants
|
2.3 index
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Weight
|
85.3 kilograms
STANDARD_DEVIATION 7.7 • n=5 Participants
|
83 kilograms
STANDARD_DEVIATION 10.2 • n=7 Participants
|
84.1 kilograms
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Body Mass Index
|
33.1 kg/m^2
STANDARD_DEVIATION 2.9 • n=5 Participants
|
34.1 kg/m^2
STANDARD_DEVIATION 3.2 • n=7 Participants
|
33.6 kg/m^2
STANDARD_DEVIATION 3.0 • n=5 Participants
|
|
Total Cholesterol
|
5.6 mmol/L
STANDARD_DEVIATION 1 • n=5 Participants
|
5 mmol/L
STANDARD_DEVIATION 0.8 • n=7 Participants
|
5.3 mmol/L
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Triglycerides
|
2.5 mmol/L
STANDARD_DEVIATION 1.5 • n=5 Participants
|
1.7 mmol/L
STANDARD_DEVIATION 0.8 • n=7 Participants
|
2.2 mmol/L
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
High Density Lipoprotein (HDL-c)
|
1.3 mmol/L
STANDARD_DEVIATION 0.3 • n=5 Participants
|
1.4 mmol/L
STANDARD_DEVIATION 0.4 • n=7 Participants
|
1.3 mmol/L
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
Alanine Aminotransferase (ALT)
|
43.8 U/L
STANDARD_DEVIATION 25.2 • n=5 Participants
|
28.8 U/L
STANDARD_DEVIATION 14.1 • n=7 Participants
|
36.3 U/L
STANDARD_DEVIATION 21.4 • n=5 Participants
|
|
Aspartate Aminotransferase (AST)
|
32.2 U/L
STANDARD_DEVIATION 17.7 • n=5 Participants
|
26.4 U/L
STANDARD_DEVIATION 7.8 • n=7 Participants
|
29.3 U/L
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Creatinine
|
63.7 umol/L
STANDARD_DEVIATION 8.8 • n=5 Participants
|
65.4 umol/L
STANDARD_DEVIATION 17.7 • n=7 Participants
|
64.6 umol/L
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Uric Acid
|
285.5 umol/L
STANDARD_DEVIATION 113 • n=5 Participants
|
273.6 umol/L
STANDARD_DEVIATION 58.9 • n=7 Participants
|
279.6 umol/L
STANDARD_DEVIATION 132.6 • n=5 Participants
|
|
Systolic blood Pressure
|
120 mmHg
STANDARD_DEVIATION 11 • n=5 Participants
|
123 mmHg
STANDARD_DEVIATION 10 • n=7 Participants
|
121.6 mmHg
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Diastolic Blood Pressure
|
78 mmHg
STANDARD_DEVIATION 7 • n=5 Participants
|
75 mmHg
STANDARD_DEVIATION 7 • n=7 Participants
|
76.4 mmHg
STANDARD_DEVIATION 7.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Postprandial glucose will be evaluated at baseline and week 12 after a oral glucose tolerance test with enzymatic-colorimetric techniques
Outcome measures
| Measure |
Artemisia Dracunculus
n=12 Participants
Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Artemisia dracunculus
|
Placebo
n=11 Participants
Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Placebo
|
|---|---|---|
|
Postprandial Glucose Levels at Week 12
|
9.5 mmol/L
Standard Deviation 1.8
|
9.9 mmol/L
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: Week 12Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Outcome measures
| Measure |
Artemisia Dracunculus
n=12 Participants
Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Artemisia dracunculus
|
Placebo
n=11 Participants
Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Placebo
|
|---|---|---|
|
Fasting Glucose Levels at Week 12
|
5.9 mmol/L
Standard Deviation 0.6
|
5.9 mmol/L
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: Week 12Glycosylated hemoglobin will be evaluated at baseline and week 12 by ELISA
Outcome measures
| Measure |
Artemisia Dracunculus
n=12 Participants
Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Artemisia dracunculus
|
Placebo
n=11 Participants
Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Placebo
|
|---|---|---|
|
Glycosylated Hemoglobin at Week 12
|
5.6 percentage
Standard Deviation 0.4
|
5.8 percentage
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: Week 12The first phase of insulin secretion will be calculated at baseline and week 12 with Stumvoll index. Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis. First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the first phase of insulin secretion
Outcome measures
| Measure |
Artemisia Dracunculus
n=12 Participants
Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Artemisia dracunculus
|
Placebo
n=11 Participants
Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Placebo
|
|---|---|---|
|
First Phase of Insulin Secretion at Week 12
|
1235 index
Standard Deviation 1047
|
1566 index
Standard Deviation 1206
|
PRIMARY outcome
Timeframe: Week 12Total insulin secretion will be calculated at baseline and week 12 with insulinogenic index. The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus. Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin/ΔABC glucose), the entered values reflect the total insulin secretion
Outcome measures
| Measure |
Artemisia Dracunculus
n=12 Participants
Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Artemisia dracunculus
|
Placebo
n=11 Participants
Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Placebo
|
|---|---|---|
|
Total Insulin Secretion at Week 12
|
0.35 index
Standard Deviation 0.2
|
0.75 index
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: Week 12Insulin sensitivity will be calculated at baseline and week 12 with Matsuda index. Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\]. The entered values reflect the insulin sensitivity
Outcome measures
| Measure |
Artemisia Dracunculus
n=12 Participants
Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Artemisia dracunculus
|
Placebo
n=11 Participants
Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Placebo
|
|---|---|---|
|
Insulin Sensitivity at Week 12
|
2.4 index
Standard Deviation 1.0
|
1.8 index
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Week 12The weight will be measured at baseline and week 12 with a bioimpedance balance
Outcome measures
| Measure |
Artemisia Dracunculus
n=12 Participants
Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Artemisia dracunculus
|
Placebo
n=11 Participants
Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Placebo
|
|---|---|---|
|
Weight at Week 12
|
85.3 kilograms
Standard Deviation 8.2
|
84.0 kilograms
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: Week 12Body Mass Index will be calculated at baseline and week 12 with the Quetelet index formula
Outcome measures
| Measure |
Artemisia Dracunculus
n=12 Participants
Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Artemisia dracunculus
|
Placebo
n=11 Participants
Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Placebo
|
|---|---|---|
|
Body Mass Index at Week 12
|
33.2 kg/m^2
Standard Deviation 2.9
|
34.4 kg/m^2
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Week 12Total cholesterol levels will be evaluated at baseline and week 12 by enzymatic-colorimetric techniques
Outcome measures
| Measure |
Artemisia Dracunculus
n=12 Participants
Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Artemisia dracunculus
|
Placebo
n=11 Participants
Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Placebo
|
|---|---|---|
|
Total Cholesterol at Week 12
|
5.4 mmol/L
Standard Deviation 1.2
|
5.0 mmol/L
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Week 12Triglycerides levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Outcome measures
| Measure |
Artemisia Dracunculus
n=12 Participants
Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Artemisia dracunculus
|
Placebo
n=11 Participants
Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Placebo
|
|---|---|---|
|
Triglycerides Levels at Week 12
|
2.2 mmol/L
Standard Deviation 0.7
|
1.8 mmol/L
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Week 12c-HDL levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Outcome measures
| Measure |
Artemisia Dracunculus
n=12 Participants
Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Artemisia dracunculus
|
Placebo
n=11 Participants
Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Placebo
|
|---|---|---|
|
High Density Lipoprotein (c-HDL) Levels at Week 12
|
1.4 mmol/L
Standard Deviation 0.3
|
1.3 mmol/L
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Week 12ALT levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Outcome measures
| Measure |
Artemisia Dracunculus
n=12 Participants
Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Artemisia dracunculus
|
Placebo
n=11 Participants
Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Placebo
|
|---|---|---|
|
Alanine Aminotransferase (ALT) Levels at Week 12
|
32.8 U/L
Standard Deviation 17.7
|
36.7 U/L
Standard Deviation 18.2
|
SECONDARY outcome
Timeframe: Week 12AST levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Outcome measures
| Measure |
Artemisia Dracunculus
n=12 Participants
Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Artemisia dracunculus
|
Placebo
n=11 Participants
Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Placebo
|
|---|---|---|
|
Aspartate Aminotransferase (AST) Levels at Week 12
|
30.3 U/L
Standard Deviation 18.1
|
26.7 U/L
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: Week 12Creatinine levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Outcome measures
| Measure |
Artemisia Dracunculus
n=12 Participants
Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Artemisia dracunculus
|
Placebo
n=11 Participants
Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Placebo
|
|---|---|---|
|
Creatinine Levels at Week 12
|
61.01 umol/L
Standard Deviation 16.8
|
61.01 umol/L
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: Week 12Uric acid levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Outcome measures
| Measure |
Artemisia Dracunculus
n=12 Participants
Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Artemisia dracunculus
|
Placebo
n=11 Participants
Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Placebo
|
|---|---|---|
|
Uric Acid Levels at Week 12
|
350.9 umol/L
Standard Deviation 71.4
|
309.3 umol/L
Standard Deviation 50.6
|
SECONDARY outcome
Timeframe: Week 12Systolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer
Outcome measures
| Measure |
Artemisia Dracunculus
n=12 Participants
Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Artemisia dracunculus
|
Placebo
n=11 Participants
Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Placebo
|
|---|---|---|
|
Systolic Blood Pressure at Week 12
|
113 mmHg
Standard Deviation 11
|
125 mmHg
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Week 12Diastolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer
Outcome measures
| Measure |
Artemisia Dracunculus
n=12 Participants
Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Artemisia dracunculus
|
Placebo
n=11 Participants
Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Placebo
|
|---|---|---|
|
Diastolic Blood Pressure at Week 12.
|
75 mmHg
Standard Deviation 8
|
79 mmHg
Standard Deviation 9
|
Adverse Events
Artemisia Dracunculus
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Artemisia Dracunculus
n=12 participants at risk
Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Artemisia dracunculus
|
Placebo
n=12 participants at risk
Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 1 • Adverse events were collected during the 12 weeks of the study.
|
16.7%
2/12 • Number of events 2 • Adverse events were collected during the 12 weeks of the study.
|
Additional Information
DR. MANUEL GONZALEZ ORTIZ
INSTITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA, UNIVERSITY OF GUADALAJARA
Phone: +52 3310585200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place