Type 2 DiabetesEarly Phase 1NCT01940302
Dietary Supplement of LEHEL for the Patients With Type 2 Diabetes
A Early Phase 1 study testing LEHEL multi-nutrients supplement in people with Type 2 Diabetes, run by Shaoguan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- LEHEL multi-nutrients supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Mar 2014
- Phase
- Early Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is diagnosed with type 2 diabetes mellitus according to the Chinese type 2 diabetes prevention guide 2010, diagnostic criteria are as follows:
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Control Before and After Supplementation With LEHEL in Patients With Type 2 Diabetes
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
- Being tested
- LEHEL multi-nutrients supplement
- Keywords
- Malnutrition; Metabolic disorders
- Medical subject headings
- Diabetes Mellitus, Type 2, Malnutrition, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEHEL multi-nutrients supplementDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| LEHEL multi-nutrients supplement | Experimental | 75 g/d of LEHEL supplementation along with oral hypoglycemic agents such as glibenclamide and/or metformin. Receives: Dietary Supplement: LEHEL multi-nutrients supplement |
| Control | No intervention | Received only oral hypoglycemic agents. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Control
Hemoglobin A1c (HbA1c) and lipids (Cholesterol, HDL-cholesterol, Triglycerides) at study entry and 12 weeks after dietary intervention
Measured: Twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaoguan University
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University
- Responsible party
- Sponsor
- Investigators
- Wenhua Ling, Ph.D., Study director, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940302
- Sponsor's protocol ID
- SGU-03
- Other IDs
- 2012BAD33B10
- Status last verified
- May 2014
- First submitted
- 7 Sep 2013
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Control Before and After Supplementation With LEHEL in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01940302
- Acronym / sponsor ID
- SGU-03
- Conditions
- Type 2 Diabetes
- Keywords
- Malnutrition; Metabolic disorders
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Shaoguan UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-sen University
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 12 Sep 2013 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEHEL multi-nutrients supplement | Experimental | Dietary Supplement: LEHEL multi-nutrients supplement75 g/d of LEHEL supplementation along with oral hypoglycemic agents such as glibenclamide and/or metformin. |
| Control | No intervention | –Received only oral hypoglycemic agents. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is diagnosed with type 2 diabetes mellitus according to the Chinese type 2 diabetes prevention guide 2010, diagnostic criteria are as follows:
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| LEHEL multi-nutrients supplementThe 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. | Dietary supplement | LEHEL multi-nutrients supplement |
Primary outcome
Metabolic Control
Time frame: Twelve weeks
Hemoglobin A1c (HbA1c) and lipids (Cholesterol, HDL-cholesterol, Triglycerides) at study entry and 12 weeks after dietary intervention
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 12 May 2014.
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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.
Wenhua Ling, Ph.D. study director
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing LEHEL multi-nutrients supplement in people with Type 2 Diabetes, run by Shaoguan University at 1 site in China.
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 5 inclusion and 8 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 12 May 2014. 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 China. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Metabolic Control (time frame: Twelve weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2014.