Diabetes MellitusSTEDIA1NCT02834715
Metabolic Effects of Stevia in Type 2 Diabetic Patients
A study testing Stevia rebaudiana liquid extract in people with Diabetes Mellitus, run by Yaounde Central Hospital at 1 site in Cameroon.
Trial summary
The main aim of the study is to assess the short term and 1-month metabolic effects of Stevia rebaudiana bertoni in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Stevia rebaudiana liquid extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCameroon
- Study dates
- Mar 2016to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Known type 2 diabetes
- Unchanged hypoglycaemic treatment for at least 3 months prior to inclusion
- No acute complication of diabetes
- HbA1C≤ 8%
Who cannot join
- Infection up to 10 days prior to inclusion
- Serum ALAT >3N,
- MDRD estimated creatinine clearance <60ml/min
- Tobacco smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Stevia on Glycaemic Profile and Insulin Secretion of Type 2 Diabetic Patients
The main aim of the study is to assess the short term and 1-month metabolic effects of Stevia rebaudiana bertoni in patients with type 2 diabetes.
Read the detailed description
This is a non-randomized clinical trial in a type 2 diabetic population aiming to investigate the effect of Stevia rebaudiana bertoni on the glycaemic and insulin secretory response to a mixed meal tolerance test, insulin sensitivity and lipid profile. The study has two arms including an intervention arm (test group) and a non-intervention arm (controls) matched for age, sex and body mass index in 2:1 ratio.
The intervention is made of two phases including
- A mixed meal tolerance test with and without 240 mg of Stevia in a randomized order to evaluate the acute effects;
- An oral intake of 240 mg of Stevia within 30 days as food supplement in order to assess medium-term effects
- Conditions
- Diabetes Mellitus
- Being tested
- Stevia rebaudiana liquid extract
- Keywords
- Diabetes, Stevia, insulin secretion, insulin sensitivity, Sweetener
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stevia rebaudiana liquid extractDietary supplement
Sweetener made of liquid stevia self administered daily for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Stevia | Experimental | Once-daily oral intake of 240 mg of Stevia liquid extract for 30 days as food supplement. Receives: Dietary Supplement: Stevia rebaudiana liquid extract |
| Control | No intervention | No intervention, similar follow up as experimental arm to control for trial effect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic profile in response to mixed meal test
Change in blood glucose profile during a mixed meal test at baseline and after one month intervention
Measured: 1 month
Secondary outcomes (4)
insulin secretion in response to mixed meal test
Change in serum C-peptide profile during a mixed meal test at baseline and after one month intervention
Measured: 1 month
Serum lipids
Change in fasting serum lipids
Measured: 1 month
Insulin sensitivity
Change in mixed meal derived insulin sensitivity
Measured: 1 month
Liver enzymes
Change in serum alanine amino transferase
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yaounde Central Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sobngwi Eugene, Yaounde Central Hospital
- Investigators
- Eugene Sobngwi, MD, PhD, Principal investigator, University of Yaoundé 1 and Yaoundé Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834715
- Sponsor's protocol ID
- CNO20161
- Acronym
- STEDIA1
- Status last verified
- Jan 2017
- First submitted
- 8 Jul 2016
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stevia on Glycaemic Profile and Insulin Secretion of Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT02834715
- Acronym / sponsor ID
- STEDIA1 / CNO20161
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes, Stevia, insulin secretion, insulin sensitivity, Sweetener
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Yaounde Central HospitalOther government
- Study start
- Mar 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 15 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of the study is to assess the short term and 1-month metabolic effects of Stevia rebaudiana bertoni in patients with type 2 diabetes.
Detailed description
This is a non-randomized clinical trial in a type 2 diabetic population aiming to investigate the effect of Stevia rebaudiana bertoni on the glycaemic and insulin secretory response to a mixed meal tolerance test, insulin sensitivity and lipid profile. The study has two arms including an intervention arm (test group) and a non-intervention arm (controls) matched for age, sex and body mass index in 2:1 ratio.
The intervention is made of two phases including
- A mixed meal tolerance test with and without 240 mg of Stevia in a randomized order to evaluate the acute effects;
- An oral intake of 240 mg of Stevia within 30 days as food supplement in order to assess medium-term effects
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stevia | Experimental | Dietary Supplement: Stevia rebaudiana liquid extractOnce-daily oral intake of 240 mg of Stevia liquid extract for 30 days as food supplement. |
| Control | No intervention | –No intervention, similar follow up as experimental arm to control for trial effect |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Known type 2 diabetes
- Unchanged hypoglycaemic treatment for at least 3 months prior to inclusion
- No acute complication of diabetes
- HbA1C≤ 8%
Key exclusion criteria (4 listed)
- Infection up to 10 days prior to inclusion
- Serum ALAT >3N,
- MDRD estimated creatinine clearance <60ml/min
- Tobacco smoking
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 |
|---|---|---|
| Stevia rebaudiana liquid extractSweetener made of liquid stevia self administered daily for 30 days | Dietary supplement | Stevia |
Primary outcome
Glycaemic profile in response to mixed meal test
Time frame: 1 month
Change in blood glucose profile during a mixed meal test at baseline and after one month intervention
4 secondary outcomes
insulin secretion in response to mixed meal test
Time frame: 1 month
Serum lipids
Time frame: 1 month
Insulin sensitivity
Time frame: 1 month
Liver enzymes
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
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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.
Eugene Sobngwi, MD, PhD principal investigator
University of Yaoundé 1 and Yaoundé Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stevia rebaudiana liquid extract in people with Diabetes Mellitus, run by Yaounde Central Hospital at 1 site in Cameroon.
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 4 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 24 Jan 2017. 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 Cameroon. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glycaemic profile in response to mixed meal test (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2017.