Clinical trial NCT02693392: Clinical Evaluation of Fenugreek Seed Extract, a Nutraceutical in Patients With Type- 2 Diabetes
Official title: Clinical Evaluation of Fenugreek Seed Extract, a Nutraceutical in Patients With Type- 2 Diabetes: An Add-On Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type-2 Diabetes Mellitus
Keywords: Fenugreek seed extract
HbA1c
Blood glucose
Lead sponsor: All India Institute of Medical Sciences, Bhubaneswar
Sponsor class: OTHER
Collaborators: name: Chemical Resources
First posted: 2016-02-26
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Glycosylated hemoglobin (HbA1c)
timeFrame: Change from baseline HbA1c over 12 weeks
Secondary outcomes:
measure: Fasting blood glucose
timeFrame: Change from baseline Fasting Blood Glucose over 12 weeks
measure: Serum Insulin
timeFrame: Change from baseline Serum Insulin over 12 weeks
measure: Serum C-Peptide
timeFrame: Change from baseline Serum C-Peptide over 12 weeks
measure: Renal Function Test
timeFrame: Change from baseline Renal function test over 12 weeks
measure: Liver Function Test
timeFrame: Change from baseline Liver function test over 12 weeks
measure: Hematology (whole blood cell count)
timeFrame: Change from baseline Hematology over 12 weeks
measure: Urinary sugar
timeFrame: Change from baseline Urinary over 12 weeks
measure: Post-prandial Blood Glucose
timeFrame: Change from baseline post-prandial Blood Glucose over 12 weeks
Other outcomes:
Locations:
city: Bhubaneswar
country: India
facility: Department of Medicine and Department of Pharmacology, AIIMS
state: Odisha
Study officials:
References:
citation: 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.
citation: Neelakantan 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.
citation: Baquer 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.
citation: Hannan 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.