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Completed

NCT Number: NCT01677611

Effects of Resveratrol in Patients With Type 2 Diabetes

Animal studies indicate that resveratrol, a phytoalexin enriched in the skin of red grapes and a constituent of red wine, is associated with longevity likely through the increased production of a protein, SIRT1.

The trial is a proof-of-concept study primarily designed to examine for the first time in humans, the effect of 12 weeks of oral resveratrol on skeletal muscle SIRT1 expression in 10 patients with T2DM in a randomized, placebo-controlled, double-blind fashion. Secondary outcomes include measures of AMPK, p-AMPK and GLUT4 expression levels, energy expenditure, physical activity levels, distribution of abdominal adipose tissue and skeletal muscle fiber type composition, body weight, HbA1c, plasma lipid subfraction, adiponectin levels and insulin sensitivity.

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Key information

Age range

40 year–69 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Alexandra Health, Khoo Teck Puat Hospital

Singapore, 768828

About this study

Eligible criteria include Chinese males, aged between 40 and 69 years old, with T2DM with a HbA1c of 7.1 to 12% and who have been on a stable oral hypoglycemic regimen for the past 3 months. Subjects who were insulin-dependent, with renal or liver impairment or who were terminally ill were excluded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to give informed consent
  • Chinese Male
  • Age 40 to 69 yrs old
  • For subjects with type 2 diabetes mellitus
  • Diagnosis of type 2 diabetes mellitus based on MOH criteria and,
  • HbA1c >6.5 during screening

Exclusion criteria

Willing to abstain from ingesting large quantities of resveratrol-containing foods (eg. red wine, nuts) Cancer diagnosis that is currently under treatment, is clinically detectable, or that has been treated within the past 5 years Terminal disease or on palliative care Current excessive alcohol intake (>21 units per week for men; 14 units per week for women) On maximal doses of 3 or > oral hypoglycaemic agents On insulin therapy or known type 1 diabetes mellitus Past history of documented or suspected hypoglycemia within last 3 months Past history of recurrent hypoglycemia Past history of serious hypoglycemia as defined by documented hypoglycemia requiring hospital admission Past history of hyperglycemic emergencies within last 6 months Past or current history of hemorrhagic strokes On anti-platelet agents, non-steroidal anti-inflammatory drugs (NSAIDs), anti-coagulation therapy or omega-3 fatty acids History of unexplained bleeding disorders History of any grape allergy History of allergy to local anaesthetic History of surgery with surgery with clips, staples or stents Presence of cardiac pacemaker or metallic foreign body in any part of the body On alternative or traditional medications Treated with another investigational drug within last 6 months Poorly controlled hypertension (SBP >/= 160 or DBP >/= 100) within last one month ALT and/or AST > 1.5 times above upper limit of normal within last 6 months GFR < 50 ml/min/1.73m2 (MDRD equation) within last 6 months

Treatment and study plan

Trans-resveratrol extract from Polygonum Cuspidatum

Drug

Starting dose of 500 mg daily of either resveratrol to be administered on Day 1 and increased by 500 mg per day every 3 days to a maximum dose of 3 g per day in three divided doses if there was no hypoglycemia.

Other names: Mega Resveratrol, Danbury, USA

Placebo

Drug

Primary outcomes

  1. Skeletal muscle sirtuin 1 (SIRT1) expression

    Time frame: 3 months

Secondary outcomes

  1. Skeletal muscle 5'-AMP-activated protein kinase (AMPK) expression

    Time frame: 3 months

  2. Skeletal muscle phosphorylated-AMPK-Thr172 (p-AMPK) expression

    Time frame: 3 months

  3. Skeletal muscle glucose transporter type 4 (GLUT 4) expression

    Time frame: 3 months

  4. Glycated hemoglobin (HbA1c)

    Time frame: 3 months

  5. Body weight

    Time frame: 3 months

  6. Insulin sensitivity

    Time frame: 3 months

  7. Lipid profile

    Time frame: 3 months

  8. Energy expenditure

    Time frame: 3 months

  9. Physical activity level

    Time frame: 3 months

  10. Abdominal adipose tissue distribution

    Time frame: 3 months

  11. Skeletal muscle fibre type composition

    Time frame: 3 months

  12. Renal function

    Time frame: 3 months

    Serum creatinine

  13. Liver function

    Time frame: 3 months

    Transaminases

Sponsors and collaborators

Lead sponsor

Khoo Teck Puat Hospital

Other

Collaborators

  • National Medical Research Council (NMRC), Singapore

Registry information

Official study title

Effects of Resveratrol in Patients With Type 2 Diabetes: The RED Trial

Acronym: RED

Important dates

Study start
2008
Primary completion
2010
Study completion
2012
First posted
Sep 3, 2012
Registry last updated
Sep 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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