Clinical Evaluation of Fenugreek Seed Extract, a Nutraceutical in Patients With Type- 2 Diabetes

NCT02693392 | Completed

• 1 other identifier: T/EM-F/Pharma/14/05
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Type-2 Diabetes Mellitus

Keywords

Fenugreek seed extract; HbA1c; Blood glucose

Outcome Measures

Primary Outcomes (1)

• Glycosylated hemoglobin (HbA1c)

  HbA1c will be evaluated using Hb variant (HPLC)

  Change from baseline HbA1c over 12 weeks

Secondary Outcomes (8)

• Fasting blood glucose

  Change from baseline Fasting Blood Glucose over 12 weeks

• Serum Insulin

  Change from baseline Serum Insulin over 12 weeks

• Serum C-Peptide

  Change from baseline Serum C-Peptide over 12 weeks

• Renal Function Test

  Change from baseline Renal function test over 12 weeks

• Liver Function Test

  Change from baseline Liver function test over 12 weeks

Study Arms (2)

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.

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.

Drug: Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea]; Dietary Supplement: Fenugreek Seed extract

Interventions

Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea] DRUG

Patients 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

Also known as: Metformin, Sulfonylurea

Control; Fenugreek

Fenugreek Seed extract DIETARY_SUPPLEMENT

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

Also known as: Capsule Fenfuro 500 mg

Fenugreek

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead
• Chemical Resources: collaborator

Study Sites (1)

Department of Medicine and Department of Pharmacology, AIIMS

Bhubaneswar, Odisha, 751019, India

Location

Related Publications (4)

• 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.

  PMID: 11868855 RESULT

• 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.

  PMID: 24438170 RESULT

• 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.

  PMID: 21654091 RESULT

• 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.

  PMID: 17313713 RESULT

MeSH Terms

Interventions

Hypoglycemic Agents; Metformin; Sulfonylurea Compounds; fenugreek seed meal

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Biguanides; Guanidines; Amidines; Organic Chemicals; Urea; Amides; Sulfones; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Head

Study Record Dates

• First Submitted: February 19, 2016
• First Posted: February 26, 2016
• Study Start: January 17, 2016
• Primary Completion: April 30, 2018
• Study Completion: August 16, 2018
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)