Impaired Glucose TolerancePhase 2NCT02708966

Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.

A Phase 2 study testing Gymnema Sylvestre in people with Impaired Glucose Tolerance, 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

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Trial summary

Who is it for?: Ages 30 to 59 years
Conditions the study is for: Impaired Glucose Tolerance
What is being tested?: Gymnema Sylvestre
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteMexico
Study dates: Mar 2016to Oct 2018
Phase: Phase 2
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 59 years
All sexes
No healthy volunteers
Adult

Who may be able to join

BMI: 25.0-34.99 kg / m2.
Diagnosis of IGT (2h-OGTT Values between 140mg / dl and 199mg / dl.)
Written informed consent.
body weight stable over the last 3 months.
Women in follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of laboratory tests.
Women who are not contemplated get pregnant within the next 6 months.

Who cannot join

Women pregnant or breastfeeding.
Physical or mental disability that makes it impossible to perform the intervention.
Diagnosis of hypertension or heart failure.
Smokers.
Untreated thyroid disease.
Consumption of oral agents or other medications or supplements with proven properties that modify the behavior of glucose and lipids (oral hypoglycemic agents, insulin, lipid-lowering).

Show all 12Show fewer

Diagnosis of liver disease or elevation twice of the upper normal value of liver enzymes.
Diagnosis of renal disease or creatinine > 1.5 mg / dl.
Diagnosis of Type 2 Diabetes Mellitus (T2DM) Fasting glucose ≥ 126 mg / dL and/or 2h-OGTT ≥ 200 mg / dL and/or A1C ≥ 6.5%.
Total Cholesterol ≥ 280 mg/dL.
Triglycerides ≥ 300 mg/dL.
Known allergy to calcined magnesia or Gymnema sylvestre.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, 44340

Other trials in Mexico

About this study

Official title: Effect of the Administration of Gymnema Sylvestre on Glycemic Control, Insulin Secretion and Insulin Sensitivity in Patients With Impaired Glucose Tolerance.

Prediabetes (PD) was defined as an state in which glucose levels are above normal but not enough to meet criteria for the diagnosis of type 2 diabetes (T2D). PD can be presented as impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and glycated hemoglobin A1c (A1C) altered. The International Diabetes Federation (IDF) reported that in 2013 the prevalence of IGT was 6.9% which is equivalent to approximately 316 million individuals with IGT, it is expected that by 2035 this number will increase to 417 million people affected. Many hypoglycemic effects attributed to Gymnema sylvestre have been reported, including: increase of insulin secretion, regeneration of pancreatic islet cells, increased glucose utilization in various ways and inhibition of glucose uptake in the intestine.

Read the detailed description

The target is to evaluate the effect of the administration of Gymnema Sylvestre on glycemic control, insulin secretion and insulin sensibility on patients with IGT. The investigators will conduct a double-blind trial, randomized, placebo control group, each group 12 female and male patients, between 30 and 59 years old with IGT (2-h values in the oral glucose tolerance test, OGTT) from 140 mg / dL to 199 mg / dL), Body Mass Index (BMI) from 25 to 34.9 kg / m2. Randomization will determine who will receive the intervention during the 9-week trial (Gymnema Sylvestre capsules, 300 mg 2 times daily with the first bite of breakfast and dinner or homologated placebo capsules). The clinical findings and laboratory tests include a metabolic profile and biosafety, which will be made at baseline and at week 9. Body weight, body fat, BMI and blood pressure will be determined during the initial and final visit. Adverse events and adherence to treatment will be documented. Statistical analysis: Mann-Whitney U test, Wilcoxon and Fisher exact test. It is considered with significance at p <0.05.

Conditions: Impaired Glucose Tolerance
Being tested: Gymnema Sylvestre, Placebo
Keywords: Gymnema Sylvestre, Glycemic control
Medical subject headings: Glucose Intolerance

What participants receive

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

Gymnema SylvestreDrug
Also called Gurmar
Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner
PlaceboDrug
Also called Calcined Magnesia
Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner

Study groups in NCT02708966
Study group	Role	What they receive
Gymnema Sylvestre	Experimental	Patients with IGT Receives: Drug: Gymnema Sylvestre
Placebo	Placebo comparator	Patients with IGT Receives: Drug: Placebo

What is being measured

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

Fasting Plasma Glucose
After intervention by spectrophotometry
Measured: 90 days
2-hour Post Load Plasma Glucose (2-h PG)
The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L.
Measured: 90 days
Glycated Hemoglobin A1c (A1C)
After intervention by high-performance liquid chromatography
Measured: 90 days
Total Insulin Secretion (Insulinogenic Index)
Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose) after intervention.
Measured: 90 days
First Phase of Insulin Secretion
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') after intervention.
Measured: 90 days
Insulin Sensitivity (Matsuda Index)
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)] after intervention.
Measured: 90 days

Secondary outcomes (13)

Area Under the Curve of Glucose
Area under the curve of glucose was obtained using the trapezoidal integration.
Measured: 90 days
Area Under the Curve of Insulin
After intervention area under the curve of insulin
Measured: 90 days
Body Weight (BW)
The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12
Measured: 12 weeks
Body Mass Index (BMI)
The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12
Measured: 12 weeks
Waist Circumference (WC)
Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflects the waist circumference measure at week 12
Measured: 12 weeks
Systolic Blood Pressure (SBP)
The Systolic Blood Pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12
Measured: 12 weeks
Diastolic Blood Pressure (DBP)
The Diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12
Measured: 12 weeks
Total Cholesterol
After intervention by spectrophotometry
Measured: 90 days
Triglycerides
After intervention by spectrophotometry
Measured: 90 days
High Density Lipoprotein Cholesterol
After intervention by spectrophotometry
Measured: 90 days
Low Density Lipoprotein
After intervention by spectrophotometry
Measured: 90 days
Very Low Density Lipoprotein
After intervention by spectrophotometry
Measured: 90 days
Creatinine
After intervention by spectrophotometry
Measured: 90 days

Timeline

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

Mar 2016Oct 2018

First posted15 Mar 2016 (estimated)
Study startMar 2016
Primary completionSep 2018
Study completionOct 2018

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 Impaired Glucose ToleranceStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02708966
Sponsor's protocol ID: GSIG
Status last verified: Jan 2021
First submitted: 10 Mar 2016
Last updated: 2 Feb 2021
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 Impaired Glucose Tolerance trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of the Administration of Gymnema Sylvestre on Glycemic Control, Insulin Secretion and Insulin Sensitivity in Patients With Impaired Glucose Tolerance.
ClinicalTrials.gov ID: NCT02708966
Acronym / sponsor ID: GSIG
Conditions: Impaired Glucose Tolerance
Keywords: Gymnema Sylvestre, Glycemic control
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: University of GuadalajaraUniversity, hospital or other
Study start: Mar 2016
Primary completion: Sep 2018 (actual)
Study completion: Oct 2018 (actual)
First posted: 15 Mar 2016 (estimated)
Results: Posted 18 Nov 2020

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Gymnema Sylvestre	Experimental	Drug: Gymnema SylvestrePatients with IGT
Placebo	Placebo comparator	Drug: PlaceboPatients with IGT

Who may qualify

Ages: 30 to 59 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

BMI: 25.0-34.99 kg / m2.
Diagnosis of IGT (2h-OGTT Values between 140mg / dl and 199mg / dl.)
Written informed consent.
body weight stable over the last 3 months.
Women in follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of laboratory tests.

Key exclusion criteria (12 listed)

Women pregnant or breastfeeding.
Physical or mental disability that makes it impossible to perform the intervention.
Diagnosis of hypertension or heart failure.
Smokers.
Untreated 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
Gymnema SylvestreAlso: GurmarGymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Drug	Gymnema Sylvestre
PlaceboAlso: Calcined MagnesiaPlacebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner	Drug	Placebo

Primary outcome

Fasting Plasma Glucose
Time frame: 90 days
After intervention by spectrophotometry
2-hour Post Load Plasma Glucose (2-h PG)
Time frame: 90 days
The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L.
Glycated Hemoglobin A1c (A1C)
Time frame: 90 days
After intervention by high-performance liquid chromatography
Total Insulin Secretion (Insulinogenic Index)
Time frame: 90 days
Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose) after intervention.
First Phase of Insulin Secretion
Time frame: 90 days
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') after intervention.
Insulin Sensitivity (Matsuda Index)
Time frame: 90 days
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)] after intervention.

13 secondary outcomes

Area Under the Curve of Glucose
Time frame: 90 days
Area Under the Curve of Insulin
Time frame: 90 days
Body Weight (BW)
Time frame: 12 weeks
Body Mass Index (BMI)
Time frame: 12 weeks
Waist Circumference (WC)
Time frame: 12 weeks
Systolic Blood Pressure (SBP)
Time frame: 12 weeks
Diastolic Blood Pressure (DBP)
Time frame: 12 weeks
Total Cholesterol
Time frame: 90 days
Triglycerides
Time frame: 90 days
High Density Lipoprotein Cholesterol
Time frame: 90 days
Low Density Lipoprotein
Time frame: 90 days
Very Low Density Lipoprotein
Time frame: 90 days
Creatinine
Time frame: 90 days

Results and safety

Results posted to the registry on 18 Nov 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
Gymnema Sylvestre	15	13
Placebo	15	13

Primary outcome: Fasting Plasma Glucose

Time frame: 90 days. Mean (Standard Deviation). Unit: mmol/L

Measure	Gymnema Sylvestre n = 13	Placebo n = 13
Value	77.4 (11.6)	77.7 (13.2)

Population analysed: All participants, including those who dropped out before the end were taken into account for statical analysis (intention to treat).

Primary outcome: 2-hour Post Load Plasma Glucose (2-h PG)

Time frame: 90 days. Mean (Standard Deviation). Unit: mmol/L

Measure	Gymnema Sylvestre n = 13	Placebo n = 13
Value	7.8 (1.7)	7.9 (1.1)

Primary outcome: Glycated Hemoglobin A1c (A1C)

Time frame: 90 days. Mean (Standard Deviation). Unit: Percent of glycated hemoglobin

Measure	Gymnema Sylvestre n = 13	Placebo n = 13
Value	5.4 (0.4)	5.7 (0.5)

Primary outcome: Total Insulin Secretion (Insulinogenic Index)

Time frame: 90 days. Mean (Standard Deviation). Unit: Unitless

Measure	Gymnema Sylvestre n = 13	Placebo n = 13
Value	0.51 (0.21)	0.49 (0.18)

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected throughout the 90 days of the study. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gymnema Sylvestre	0 of 15 (0%)	4 of 15 (26.7%)	0 of 15
Placebo	0 of 15 (0%)	6 of 15 (40%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
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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.

Esperanza Martínez-Abundis, PhD principal investigator

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, 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 Phase 2 study testing Gymnema Sylvestre in people with Impaired Glucose Tolerance, 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 6 inclusion and 12 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 2 Feb 2021. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 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?

Fasting Plasma Glucose (time frame: 90 days). 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 NCT02708966.

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 2 Feb 2021.