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Type 2 DiabetesPhase 2/3Mul-DMNCT00795704

Impact of Mulberry Leaf on Type 2 Diabetes

A Phase 2/3 study testing Mulberry Leaf Extract in people with Type 2 Diabetes, run by University of Mississippi Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate whether mulberry leaf extract will help control blood sugar in patients with type 2 diabetes. We also want to look at the safety of mulberry leaf extract in these patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Mulberry Leaf Extract
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteUnited States
Study dates
Apr 2008to May 2010
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 diabetes
  • No diabetes medication adjustments for at least 2 months
  • Stable hemoglobin A1C [Between 7.0% to 8.0% (inclusive) and not varying by more than 10% since prior visit; If no A1C exists prior to the current visit and no medication adjustments are made, the current A1C may used as the baseline]

Who cannot join

  • On insulin
  • History of overt cardiovascular disease
  • History of missed appointments or non-compliance with medications
  • History of hepatic or renal insufficiency
  • History of hemoglobinopathies
  • Women of reproductive potential not on oral contraceptives
  • Pregnant/nursing women.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

Other trials in United States

About this study

Official title: Effect of Mulberry Leaf Extract on Glycemic Durability in Non-insulin Dependent Diabetes Mellitus: a Double-blind, Randomized, Placebo-controlled Pilot Study (Mul-DM)

The purpose of this study is to evaluate whether mulberry leaf extract will help control blood sugar in patients with type 2 diabetes. We also want to look at the safety of mulberry leaf extract in these patients.

Read the detailed description

The methods for testing this hypothesis include: a 2-week placebo run-in, followed by a double-blind randomization into 2 groups: (1) mulberry leaf extract and (2) matching placebo. Evaluations of hemoglobin A1C (A1C) -- A measurement of blood glucose over the past 3 months -- will be done at baseline [before placebo run-in period] and 3 months. Evaluations of safety laboratories and adverse effect questionnaire will be done at 4 weeks and at 3 months following the randomization visit. Subjects will undergo a 2-week placebo run-in phase, and then will be divided into two groups: (1) mulberry leaf extract and (2) matching placebo. The subjects will ingest 1000 mg (#2 500 mg capsules) of standardized mulberry leaf extract (Nature-Gen, San Diego, CA) or matching placebo three times daily with meals for 3 months. Patients will be asked to monitor fasting morning blood glucose and 2-hour postprandial dinner blood glucose daily during the 2-week placebo run-in. To ensure compliance, only subjects compliant with both medication and monitoring instructions will be issued a 30-day supply of study medication at enrollment and the remainder at the 4-week safety visit. Each visit will consist of clinical examination, completed questionnaires, evaluation of self-monitoring blood glucose (SMBG), and donated blood for clinical laboratory tests. Standard recommendations for therapeutic lifestyle intervention will be given to both groups. All the clinical laboratory tests will be performed at the University of Mississippi Medical Center. All patients will receive identical 2-week placebo phase capsules, and then be randomized to each group using similar lookin

Conditions
Type 2 Diabetes
Being tested
Mulberry Leaf Extract, Placebo
Keywords
Herbal Supplement, Type 2 Diabetes, Mulberry, Hemoglobin A1C
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mulberry Leaf ExtractDrug

    Also called Mulberry, Morus indica L., Morus alba

    Mulberry Leaf Extract 1000 mg by mouth three times daily for 3 months

  • PlaceboDrug

    Placebo 500 mg #2 capsules by mouth three times daily

Study groups in NCT00795704
Study groupRoleWhat they receive
PlaceboPlacebo comparatorControl Group
Receives: Drug: Placebo
Mulberry Leaf ExtractActive comparatorNot described
Receives: Drug: Mulberry Leaf Extract

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemoglobin A1C

    Measured: 3 month minus baseline

Secondary outcomes (2)

  1. Number of Participants With Adverse Drug Reactions, Abnormal Metabolic Panel Levels, or Abnormal Liver Enzyme Levels

    Sodium (>150 mmol/L), Potassium (>5 mmol/L), Bicarbonate (>34 mmol/L), Chloride (>110 mmol/L), Serum Creatinine (>1.2 mg/dL), Blood Urea Nitrogen (24 mg/dL), Calcium (>11 mg/L), Alanine Aminotransferase (>3 times baseline), Aspartate Aminotransferase (>3 times baseline) were collected at baseline, 1 month, and 3 months. Self-Reported adverse drug reactions are also reported.

    Measured: Baseline, 1 month, and 3 months

  2. Change From Baseline in Self-Monitoring Blood Glucose (SMBG) Averages

    2-hour postprandial SMBG reported. A negative value indicates a decrease from baseline. A positive value indicates an increase from baseline.

    Measured: Baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionMay 2010
  4. Study completionMay 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00795704
Sponsor's protocol ID
2008-0053
Acronym
Mul-DM
Status last verified
Jun 2012
First submitted
19 Nov 2008
Last updated
9 Aug 2012
Data monitoring committee
No

Publications

  • Andallu B, Varadacharyulu NC. Gluconeogenic substrates and hepatic gluconeogenic enzymes in streptozotocin-diabetic rats: effect of mulberry (Morus indica L.) leaves. J Med Food. 2007 Mar;10(1):41-8. doi: 10.1089/jmf.2005.034.

    PubMed 17472465

  • Mudra M, Ercan-Fang N, Zhong L, Furne J, Levitt M. Influence of mulberry leaf extract on the blood glucose and breath hydrogen response to ingestion of 75 g sucrose by type 2 diabetic and control subjects. Diabetes Care. 2007 May;30(5):1272-4. doi: 10.2337/dc06-2120. Epub 2007 Feb 15. No abstract available.

    PubMed 17303787

  • Hansawasdi C, Kawabata J. Alpha-glucosidase inhibitory effect of mulberry (Morus alba) leaves on Caco-2. Fitoterapia. 2006 Dec;77(7-8):568-73. doi: 10.1016/j.fitote.2006.09.003. Epub 2006 Sep 22.

    PubMed 17071014

  • Zhong L, Furne JK, Levitt MD. An extract of black, green, and mulberry teas causes malabsorption of carbohydrate but not of triacylglycerol in healthy volunteers. Am J Clin Nutr. 2006 Sep;84(3):551-5. doi: 10.1093/ajcn/84.3.551.

    PubMed 16960168

  • Riche DM, Riche KD, East HE, Barrett EK, May WL. Impact of mulberry leaf extract on type 2 diabetes (Mul-DM): A randomized, placebo-controlled pilot study. Complement Ther Med. 2017 Jun;32:105-108. doi: 10.1016/j.ctim.2017.04.006. Epub 2017 Apr 27.

    PubMed 28619294

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Mulberry Leaf Extract in people with Type 2 Diabetes, run by University of Mississippi Medical Center at 1 site in United States.

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 3 inclusion and 7 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 9 Aug 2012. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Hemoglobin A1C (time frame: 3 month minus baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00795704, which also lists 5 linked publications.

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 9 Aug 2012.

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