Type-2 Diabetes MellitusNCT02693392
Clinical Evaluation of Fenugreek Seed Extract, a Nutraceutical in Patients With Type- 2 Diabetes
A study testing Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea] and Fenugreek Seed extract in people with Type-2 Diabetes Mellitus, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial summary
In the proposed study, hydroalcoholic Fenugreek seed extract will used add-on to the existing therapy in patients with type-2 diabetes. The efficacy and safety of the extract will be evaluated using standard methodology. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Type-2 Diabetes Mellitus
- What is being tested?
- Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea] and Fenugreek Seed extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- 17 Jan 2016to 16 Aug 2018
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from Type-2 Diabetes of less than 10 years duration
- Patients with HbA1c >7.0%
- Patients with fasting plasma glucose not exceeding 180 mg/dL
- Patients with Negative Urine sugar
- Patients who are on oral hypoglycaemic agents containing either Metformin or Sulfonylurea or both
- There should not be any change their in anti-diabetic treatment for at least one month
Who cannot join
- Patients with diabetes other than type-2 diabetes mellitus
- Patients with evidence of renal disease (S. Creatinine > 1.5mg/dL)
- Patients with evidence of liver disease (AST/ALT >3 times of normal
- Pregnant and lactating mothers and women intending pregnancy
- Patients who participated in any other clinical trial within the last 30 days
- Patients with history of any hemoglobinopathy
- History of intolerance or hypersensitivity to Fenugreek
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Medicine and Department of Pharmacology, AIIMS
Bhubaneswar, Odisha, 751019
About this study
Official title: Clinical Evaluation of Fenugreek Seed Extract, a Nutraceutical in Patients With Type- 2 Diabetes: An Add-On Study
In the proposed study, hydroalcoholic Fenugreek seed extract will used add-on to the existing therapy in patients with type-2 diabetes. The efficacy and safety of the extract will be evaluated using standard methodology.
Read the detailed description
Trigonella foenum-graecum, commonly known as Fenugreek, is a plant that has been extensively used as a source of antidiabetic compounds, from its seeds, leaves and extracts in different systems of medicine in asia. Fenugreek is traditionally used in India, especially in the Ayurvedic and Unani systems. Preliminary animal and human studies suggest possible hypoglycemic and anti-hyperlipidemic properties of fenugreek seed powder taken orally. In a randomized placebo controlled study conducted by Gupta et al showed that two month treatment with the hydro-alcoholic extract of fenugreek seeds improved glycemic control in 12 non-insulin dependent diabetes mellitus patients. In addition, there was improvement in insulin sensitivity and plasma lipid profile. Fenugreek extract was also well tolerated in diabetic patients.
In the proposed study, hydroalcoholic Fenugreek seed extract will used add-on to the existing therapy in patients with type-2 diabetes. The efficacy and safety of the extract will be evaluated using standard methodology.
- Conditions
- Type-2 Diabetes Mellitus
- Being tested
- Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea], Fenugreek Seed extract
- Keywords
- Fenugreek seed extract, HbA1c, Blood glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea]Drug
Also called Metformin, Sulfonylurea
Patients receiving either of the following oral hypoglycemic agents
- Sulfonylurea based oral hypoglycemic agents
- Metformin based oral hypoglycemic agents
- Metformin plus Sulfonylurea based oral hypoglycemic agents
Fenugreek Seed extractDietary supplement
Also called Capsule Fenfuro 500 mg
Patients recruited in the study arm will receive Capsule Fenfuro 500 milligram twice daily for 12 weeks as add-on intervention to the pre-specified oral hypoglycemic agents therapy
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | One hundred type-2 diabetes patients with standard oral hypoglycemic drugs (metformin +/- sulfonylurea) will be recruited and followed up without add-on fenugreek extract. Receives: Drug: Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea] |
| Fenugreek | Experimental | One hundred type-2 diabetes patients with standard oral hypoglycemic drugs (metformin +/- sulfonylurea) will be recruited and followed up with add-on fenugreek extract. Receives: Drug: Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea]; Dietary Supplement: Fenugreek Seed extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated hemoglobin (HbA1c)
HbA1c will be evaluated using Hb variant (HPLC)
Measured: Change from baseline HbA1c over 12 weeks
Secondary outcomes (8)
Fasting blood glucose
METHOD : SPECTROPHOTOMETRY HEXOKINASE
Measured: Change from baseline Fasting Blood Glucose over 12 weeks
Serum Insulin
by CHEMILUMINESCENCE method
Measured: Change from baseline Serum Insulin over 12 weeks
Serum C-Peptide
by CHEMILUMINESCENCE method
Measured: Change from baseline Serum C-Peptide over 12 weeks
Renal Function Test
by Spectrophotometry
Measured: Change from baseline Renal function test over 12 weeks
Liver Function Test
by Spectrophotometry
Measured: Change from baseline Liver function test over 12 weeks
Hematology (whole blood cell count)
Automated particle cell counter and microscopy
Measured: Change from baseline Hematology over 12 weeks
Urinary sugar
Semi-quantitative Biochemical test
Measured: Change from baseline Urinary over 12 weeks
Post-prandial Blood Glucose
METHOD: SPECTROPHOTOMETRY HEXOKINASE
Measured: Change from baseline post-prandial Blood Glucose over 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study start17 Jan 2016
- Primary completion30 Apr 2018
- Study completion16 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type-2 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Collaborators
- Chemical Resources
- Responsible party
- Principal investigator, Dr Debasish Hota, All India Institute of Medical Sciences, Bhubaneswar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693392
- Sponsor's protocol ID
- T/EM-F/Pharma/14/05
- Status last verified
- Aug 2018
- First submitted
- 19 Feb 2016
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gupta A, Gupta R, Lal B. Effect of Trigonella foenum-graecum (fenugreek) seeds on glycaemic control and insulin resistance in type 2 diabetes mellitus: a double blind placebo controlled study. J Assoc Physicians India. 2001 Nov;49:1057-61.
PubMed 11868855Neelakantan N, Narayanan M, de Souza RJ, van Dam RM. Effect of fenugreek (Trigonella foenum-graecum L.) intake on glycemia: a meta-analysis of clinical trials. Nutr J. 2014 Jan 18;13:7. doi: 10.1186/1475-2891-13-7.
PubMed 24438170Baquer NZ, Kumar P, Taha A, Kale RK, Cowsik SM, McLean P. Metabolic and molecular action of Trigonella foenum-graecum (fenugreek) and trace metals in experimental diabetic tissues. J Biosci. 2011 Jun;36(2):383-96. doi: 10.1007/s12038-011-9042-0.
PubMed 21654091Hannan JM, Ali L, Rokeya B, Khaleque J, Akhter M, Flatt PR, Abdel-Wahab YH. Soluble dietary fibre fraction of Trigonella foenum-graecum (fenugreek) seed improves glucose homeostasis in animal models of type 1 and type 2 diabetes by delaying carbohydrate digestion and absorption, and enhancing insulin action. Br J Nutr. 2007 Mar;97(3):514-21. doi: 10.1017/S0007114507657869.
PubMed 17313713
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Fenugreek Seed Extract, a Nutraceutical in Patients With Type- 2 Diabetes: An Add-On Study
- ClinicalTrials.gov ID
- NCT02693392
- Acronym / sponsor ID
- T/EM-F/Pharma/14/05
- Conditions
- Type-2 Diabetes Mellitus
- Keywords
- Fenugreek seed extract, HbA1c, Blood glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Collaborators
- Chemical Resources
- Study start
- 17 Jan 2016 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 16 Aug 2018 (actual)
- First posted
- 26 Feb 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.
In the proposed study, hydroalcoholic Fenugreek seed extract will used add-on to the existing therapy in patients with type-2 diabetes. The efficacy and safety of the extract will be evaluated using standard methodology.
Detailed description
Trigonella foenum-graecum, commonly known as Fenugreek, is a plant that has been extensively used as a source of antidiabetic compounds, from its seeds, leaves and extracts in different systems of medicine in asia. Fenugreek is traditionally used in India, especially in the Ayurvedic and Unani systems. Preliminary animal and human studies suggest possible hypoglycemic and anti-hyperlipidemic properties of fenugreek seed powder taken orally. In a randomized placebo controlled study conducted by Gupta et al showed that two month treatment with the hydro-alcoholic extract of fenugreek seeds improved glycemic control in 12 non-insulin dependent diabetes mellitus patients. In addition, there was improvement in insulin sensitivity and plasma lipid profile. Fenugreek extract was also well tolerated in diabetic patients.
In the proposed study, hydroalcoholic Fenugreek seed extract will used add-on to the existing therapy in patients with type-2 diabetes. The efficacy and safety of the extract will be evaluated using standard methodology.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea]One hundred type-2 diabetes patients with standard oral hypoglycemic drugs (metformin +/- sulfonylurea) will be recruited and followed up without add-on fenugreek extract. |
| Fenugreek | Experimental | Drug: Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea], Dietary Supplement: Fenugreek Seed extractOne hundred type-2 diabetes patients with standard oral hypoglycemic drugs (metformin +/- sulfonylurea) will be recruited and followed up with add-on fenugreek extract. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients suffering from Type-2 Diabetes of less than 10 years duration
- Patients with HbA1c >7.0%
- Patients with fasting plasma glucose not exceeding 180 mg/dL
- Patients with Negative Urine sugar
- Patients who are on oral hypoglycaemic agents containing either Metformin or Sulfonylurea or both
Key exclusion criteria (7 listed)
- Patients with diabetes other than type-2 diabetes mellitus
- Patients with evidence of renal disease (S. Creatinine > 1.5mg/dL)
- Patients with evidence of liver disease (AST/ALT >3 times of normal
- Pregnant and lactating mothers and women intending pregnancy
- Patients who participated in any other clinical trial within the last 30 days
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 |
|---|---|---|
| Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea]Also: Metformin, SulfonylureaPatients receiving either of the following oral hypoglycemic agents 1. Sulfonylurea based oral hypoglycemic agents 2. Metformin based oral hypoglycemic agents 3. Metformin plus Sulfonylurea based oral hypoglycemic agents | Drug | Control, Fenugreek |
| Fenugreek Seed extractAlso: Capsule Fenfuro 500 mgPatients recruited in the study arm will receive Capsule Fenfuro 500 milligram twice daily for 12 weeks as add-on intervention to the pre-specified oral hypoglycemic agents therapy | Dietary supplement | Fenugreek |
Primary outcome
Glycosylated hemoglobin (HbA1c)
Time frame: Change from baseline HbA1c over 12 weeks
HbA1c will be evaluated using Hb variant (HPLC)
8 secondary outcomes
Fasting blood glucose
Time frame: Change from baseline Fasting Blood Glucose over 12 weeks
Serum Insulin
Time frame: Change from baseline Serum Insulin over 12 weeks
Serum C-Peptide
Time frame: Change from baseline Serum C-Peptide over 12 weeks
Renal Function Test
Time frame: Change from baseline Renal function test over 12 weeks
Liver Function Test
Time frame: Change from baseline Liver function test over 12 weeks
Hematology (whole blood cell count)
Time frame: Change from baseline Hematology over 12 weeks
Urinary sugar
Time frame: Change from baseline Urinary over 12 weeks
Post-prandial Blood Glucose
Time frame: Change from baseline post-prandial Blood Glucose over 12 weeks
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 17 Aug 2018.
- Results publication: PubMed 11868855Gupta A, Gupta R, Lal B. Effect of Trigonella foenum-graecum (fenugreek) seeds on glycaemic control and insulin resistance in type 2 diabetes mellitus: a double blind placebo controlled study. J Assoc Physicians India. 2001 Nov;49:1057-61.
- Results publication: PubMed 24438170Neelakantan N, Narayanan M, de Souza RJ, van Dam RM. Effect of fenugreek (Trigonella foenum-graecum L.) intake on glycemia: a meta-analysis of clinical trials. Nutr J. 2014 Jan 18;13:7. doi: 10.1186/1475-2891-13-7.
- Results publication: PubMed 21654091Baquer NZ, Kumar P, Taha A, Kale RK, Cowsik SM, McLean P. Metabolic and molecular action of Trigonella foenum-graecum (fenugreek) and trace metals in experimental diabetic tissues. J Biosci. 2011 Jun;36(2):383-96. doi: 10.1007/s12038-011-9042-0.
- Results publication: PubMed 17313713Hannan JM, Ali L, Rokeya B, Khaleque J, Akhter M, Flatt PR, Abdel-Wahab YH. Soluble dietary fibre fraction of Trigonella foenum-graecum (fenugreek) seed improves glucose homeostasis in animal models of type 1 and type 2 diabetes by delaying carbohydrate digestion and absorption, and enhancing insulin action. Br J Nutr. 2007 Mar;97(3):514-21. doi: 10.1017/S0007114507657869.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea] and Fenugreek Seed extract in people with Type-2 Diabetes Mellitus, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
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 7 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 17 Aug 2018. 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 India. 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?
Glycosylated hemoglobin (HbA1c) (time frame: Change from baseline HbA1c over 12 weeks). 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 NCT02693392, which also lists 4 linked publications.
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 17 Aug 2018.