Dietary Supplement of LEHEL for the Patients With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Metabolic Control Before and After Supplementation With LEHEL in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940302
• Other study ID #: SGU-03
• Secondary ID: 2012BAD33B10
• Status: Completed
• Phase: Phase 0
• First received: September 7, 2013
• Last updated: May 8, 2014
• Start date: June 2013
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: Shaoguan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
China	Shaoguan University	Shaoguan	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Shaoguan University	Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic Control	Hemoglobin A1c (HbA1c) and lipids (Cholesterol, HDL-cholesterol, Triglycerides) at study entry and 12 weeks after dietary intervention	Twelve weeks	No