Dietary Supplement of LEHEL for the Patients With Type 2 Diabetes

NCT ID: NCT01940302

Last Updated: 2014-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-03-31

Brief Summary

Due to metabolic disorders and dietary restrictions, patients with diabetes may have different degrees of malnutrition. The primary objective of this study is to investigate whether supplementation of LEHEL, a multi-nutrients supplement, is capable to improve metabolic parameters in patients with type 2 diabetes.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LEHEL multi-nutrients supplement

75 g/d of LEHEL supplementation along with oral hypoglycemic agents such as glibenclamide and/or metformin.

Group Type: EXPERIMENTAL

LEHEL multi-nutrients supplement

Intervention Type: DIETARY_SUPPLEMENT

The primary objective of this study is to evaluate the effect of a diet program including LEHEL multi-nutrients supplement as breakfast replacement on metabolic control after 12-week intervention in subjects with type 2 diabetes.

Control

Received only oral hypoglycemic agents.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

LEHEL multi-nutrients supplement

The primary objective of this study is to evaluate the effect of a diet program including LEHEL multi-nutrients supplement as breakfast replacement on metabolic control after 12-week intervention in subjects with type 2 diabetes.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Subject is diagnosed with type 2 diabetes mellitus according to the Chinese type 2 diabetes prevention guide 2010, diagnostic criteria are as follows:

(1) Diabetes symptoms（polydipsia、polyphagia, polyuria, weight loss、skin itching、blurred vision and other acute metabolic network disorder that caused by high blood sugar）combined with random blood sugar ≥11.1 OR, (2) fasting plasma glucose (FPG) ≥7.0 OR, (3) 2 h blood sugar after oral glucose tolerance test (OGTT) ≥11.1;

• Subject is between 18 and 75 years of age, inclusive.
• Subject's BMI is >18.5 kg/m2 and <35 kg/m2.
• If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit.

Exclusion Criteria

• Subject that is diagnosed as type 1 diabetes, gestational diabetes and other kinds of diabetes expect type 2.
• Subject that use exogenous insulin for glucose control.
• Subject that has a history of diabetic ketoacidosis.
• Subject that has mental disorder, cancer, cirrhosis, renal disease and hepatic disease.
• Subject that has had a significant cardiovascular event less than six months prior to screening visit or has history of congestive heart failure.
• Subject that has had operation less than six months prior to screening visit.
• Subject that has taken/is currently taking any dietary supplements or medications that could profoundly affect blood glucose during the past one month prior to screening visit.
• Subject is known to be allergic or intolerant to any ingredient found in the study product.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Shaoguan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wenhua Ling, Ph.D.

Role: STUDY_DIRECTOR

Sun Yat-sen University

Locations

Shaoguan University

Shaoguan, Guangdong, China

Countries

China

Other Identifiers

2012BAD33B10

Identifier Type: OTHER

Identifier Source: secondary_id

SGU-03

Identifier Type: -

Identifier Source: org_study_id