Glucose IntoleranceNCT02330341

Effect of Artemisia Dracunculus on Glucose Intolerance, Insulin Sensitivity and Insulin Secretion

A study testing Artemisia dracunculus in people with Glucose Intolerance, run by University of Guadalajara at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The term prediabetes has been used to encompass the first alterations on glucose metabolism such as impaired fasting glucose and glucose intolerance, and its early detection and treatment could prevent the appearance of diabetes mellitus type 2, a high prevalence disease worldwide. Read more about this study

Who is it for?: Ages 30 to 60 years
Conditions the study is for: Glucose Intolerance
What is being tested?: Artemisia dracunculus
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteMexico
Study dates: Dec 2014to Jul 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patients both sexes
Age between 30 and 60 years
Glucose intolerance according ADA criteria (blood glucose leve ≥140 mg/dl and ≤199 mg/dL after an oral glucose tolerance test with 75 of oral glucose
Informed consent signed

Who cannot join

Women with confirmed or suspected pregnancy
Women under lactation and/or puerperium
Hypersensibility to Artemisia dracunculus
Physical impossibility for taking pills
Known uncontrolled renal, hepatic, heart or thyroid disease
Previous treatment for glucose
Diabetes diagnosis
BMI ≥39.9 kg/m2

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Manuel González Ortiz
Guadalajara, Jalisco, 44140

Other trials in Mexico

About this study

Artemisia dracunculus, also known as estragon, has been used in Ayurvedic medicine for the treatment of diabetes.

Different in vitro and in vivo studies have shown that Artemisia dracunculus increases insulin signaling and improves insulin sensitivity.

The aim of this study is evaluate the effect of Artemisia dracunculus on glucose intolerance, insulin sensitivity and insulin secretion.

Read the detailed description

A randomized, double-blind, placebo-controlled clinical trial will be carried out in 24 patients with diagnosis of glucose intolerance in accordance with the criteria of American Diabetes Association (ADA). Glucose, insulin levels, lipid profile, creatinine, uric acid, and transaminases will be evaluated. An oral glucose tolerance test with 75 g of dextrose will be held.

12 participants will receive Artemisia dracunculus, 1000 mg, twice per day (2000 mg) before breakfast and dinner during 3 months. And other 12 patients will receive placebo with the same prescription.

Area Under de Curve of glucose and insulin will be calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).

This protocol is approved by a local ethics committee and written informed consent will be obtained from all volunteers.

Results will be presented as mean and standard deviation. Intra an inter group differences will be tested using the Wilcoxon signed-ran and Mann Whitney U- test respectively; p<0.05 will be considered significant.

Conditions: Glucose Intolerance
Being tested: Artemisia dracunculus, Placebo
Keywords: Glucose Intolerance, Artemisia dracunculus, Insulin
Medical subject headings: Glucose Intolerance, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Artemisia dracunculusDietary supplement
Also called estragon, tarragon
PlaceboOther
Also called calcined magnesia

Study groups in NCT02330341
Study group	Role	What they receive
Artemisia Dracunculus	Experimental	Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Receives: Dietary Supplement: Artemisia dracunculus
Placebo	Placebo comparator	Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Postprandial Glucose Levels at Week 12
Postprandial glucose will be evaluated at baseline and week 12 after a oral glucose tolerance test with enzymatic-colorimetric techniques
Measured: Week 12
Fasting Glucose Levels at Week 12
Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Measured: Week 12
Glycosylated Hemoglobin at Week 12
Glycosylated hemoglobin will be evaluated at baseline and week 12 by ELISA
Measured: Week 12
First Phase of Insulin Secretion at Week 12
The 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
Measured: Week 12
Total Insulin Secretion at Week 12
Total 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
Measured: Week 12
Insulin Sensitivity at Week 12
Insulin 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
Measured: Week 12

Secondary outcomes (11)

Weight at Week 12
The weight will be measured at baseline and week 12 with a bioimpedance balance
Measured: Week 12
Body Mass Index at Week 12
Body Mass Index will be calculated at baseline and week 12 with the Quetelet index formula
Measured: Week 12
Total Cholesterol at Week 12
Total cholesterol levels will be evaluated at baseline and week 12 by enzymatic-colorimetric techniques
Measured: Week 12
Triglycerides Levels at Week 12
Triglycerides levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Measured: Week 12
High Density Lipoprotein (c-HDL) Levels at Week 12
c-HDL levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Measured: Week 12
Alanine Aminotransferase (ALT) Levels at Week 12
ALT levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Measured: Week 12
Aspartate Aminotransferase (AST) Levels at Week 12
AST levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Measured: Week 12
Creatinine Levels at Week 12
Creatinine levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Measured: Week 12
Uric Acid Levels at Week 12
Uric acid levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Measured: Week 12
Systolic Blood Pressure at Week 12
Systolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer
Measured: Week 12
Diastolic Blood Pressure at Week 12.
Diastolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2014Jul 2015

First posted1 Jan 2015 (estimated)
Study startDec 2014
Primary completionJun 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Glucose IntoleranceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a study with two groups of patients with prediabetes. One group received the investigational product (Artemisia Dracunculus) and the other received placebo as control.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02330341
Sponsor's protocol ID: GI-ESTRAGON
Status last verified: Sep 2020
First submitted: 30 Dec 2014
Last updated: 8 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Glucose Intolerance trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Artemisia Dracunculus on Glucose Intolerance, Insulin Sensitivity and Insulin Secretion
ClinicalTrials.gov ID: NCT02330341
Acronym / sponsor ID: GI-ESTRAGON
Conditions: Glucose Intolerance
Keywords: Glucose Intolerance, Artemisia dracunculus, Insulin
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: University of GuadalajaraUniversity, hospital or other
Study start: Dec 2014 (actual)
Primary completion: Jun 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 1 Jan 2015 (estimated)
Results: Posted 8 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Artemisia dracunculus, also known as estragon, has been used in Ayurvedic medicine for the treatment of diabetes.

Different in vitro and in vivo studies have shown that Artemisia dracunculus increases insulin signaling and improves insulin sensitivity.

The aim of this study is evaluate the effect of Artemisia dracunculus on glucose intolerance, insulin sensitivity and insulin secretion.

Detailed description

This protocol is approved by a local ethics committee and written informed consent will be obtained from all volunteers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: This is a study with two groups of patients with prediabetes. One group received the investigational product (Artemisia Dracunculus) and the other received placebo as control.

Arm	Type	Receives
Artemisia Dracunculus	Experimental	Dietary Supplement: Artemisia dracunculusArtemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Placebo	Placebo comparator	Other: PlaceboCalcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days

Who may qualify

Ages: 30 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Patients both sexes
Age between 30 and 60 years
Glucose intolerance according ADA criteria (blood glucose leve ≥140 mg/dl and ≤199 mg/dL after an oral glucose tolerance test with 75 of oral glucose
Informed consent signed

Key exclusion criteria (8 listed)

Women with confirmed or suspected pregnancy
Women under lactation and/or puerperium
Hypersensibility to Artemisia dracunculus
Physical impossibility for taking pills
Known uncontrolled renal, hepatic, heart or thyroid disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Artemisia dracunculusAlso: estragon, tarragon	Dietary supplement	Artemisia Dracunculus
PlaceboAlso: calcined magnesia	Other	Placebo

Primary outcome

Postprandial Glucose Levels at Week 12
Time frame: Week 12
Postprandial glucose will be evaluated at baseline and week 12 after a oral glucose tolerance test with enzymatic-colorimetric techniques
Fasting Glucose Levels at Week 12
Time frame: Week 12
Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Glycosylated Hemoglobin at Week 12
Time frame: Week 12
Glycosylated hemoglobin will be evaluated at baseline and week 12 by ELISA
First Phase of Insulin Secretion at Week 12
Time frame: Week 12
The 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
Total Insulin Secretion at Week 12
Time frame: Week 12
Total 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
Insulin Sensitivity at Week 12
Time frame: Week 12
Insulin 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

11 secondary outcomes

Weight at Week 12
Time frame: Week 12
Body Mass Index at Week 12
Time frame: Week 12
Total Cholesterol at Week 12
Time frame: Week 12
Triglycerides Levels at Week 12
Time frame: Week 12
High Density Lipoprotein (c-HDL) Levels at Week 12
Time frame: Week 12
Alanine Aminotransferase (ALT) Levels at Week 12
Time frame: Week 12
Aspartate Aminotransferase (AST) Levels at Week 12
Time frame: Week 12
Creatinine Levels at Week 12
Time frame: Week 12
Uric Acid Levels at Week 12
Time frame: Week 12
Systolic Blood Pressure at Week 12
Time frame: Week 12
Diastolic Blood Pressure at Week 12.
Time frame: Week 12

Results and safety

Results posted to the registry on 8 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Artemisia Dracunculus	12	12
Placebo	12	11

Primary outcome: Postprandial Glucose Levels at Week 12

Time frame: Week 12. Mean (Standard Deviation). Unit: mmol/L

Measure	Artemisia Dracunculus n = 12	Placebo n = 11
Value	9.5 (1.8)	9.9 (2.5)

Artemisia Dracunculus: p = 0.380, Wilcoxon (Mann-Whitney)
Placebo: p = 0.695, Wilcoxon (Mann-Whitney)

Primary outcome: Fasting Glucose Levels at Week 12

Time frame: Week 12. Mean (Standard Deviation). Unit: mmol/L

Measure	Artemisia Dracunculus n = 12	Placebo n = 11
Value	5.9 (0.6)	5.9 (0.6)

Artemisia Dracunculus: p = 0.110, Wilcoxon (Mann-Whitney)
Placebo: p = 0.910, Wilcoxon (Mann-Whitney)

Primary outcome: Glycosylated Hemoglobin at Week 12

Time frame: Week 12. Mean (Standard Deviation). Unit: percentage

Measure	Artemisia Dracunculus n = 12	Placebo n = 11
Value	5.6 (0.4)	5.8 (0.4)

Artemisia Dracunculus: p = 0.010, Wilcoxon (Mann-Whitney)
Placebo: p = 0.938, Wilcoxon (Mann-Whitney)

Primary outcome: First Phase of Insulin Secretion at Week 12

Time frame: Week 12. Mean (Standard Deviation). Unit: index

Measure	Artemisia Dracunculus n = 12	Placebo n = 11
Value	1235 (1047)	1566 (1206)

Artemisia Dracunculus: p = 0.733, Wilcoxon (Mann-Whitney)
Placebo: p = 1.0, Wilcoxon (Mann-Whitney)

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected during the 12 weeks of the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Artemisia Dracunculus	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Placebo	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MANUEL GONZALEZ, PhD principal investigator

University of Guadalajara

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Artemisia dracunculus in people with Glucose Intolerance, run by University of Guadalajara at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postprandial Glucose Levels at Week 12 (time frame: Week 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02330341.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.