Effects of Resveratrol in Patients With Type 2 Diabetes (RED)

This study has been completed.
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
Kian Peng Goh, Khoo Teck Puat Hospital
ClinicalTrials.gov Identifier:
NCT01677611
First received: August 30, 2012
Last updated: August 31, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: Trans-resveratrol extract from Polygonum Cuspidatum
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Resveratrol in Patients With Type 2 Diabetes: The RED Trial

Resource links provided by NLM:


Further study details as provided by Khoo Teck Puat Hospital:

Primary Outcome Measures:
  • Skeletal muscle sirtuin 1 (SIRT1) expression [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Skeletal muscle 5'-AMP-activated protein kinase (AMPK) expression [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Skeletal muscle phosphorylated-AMPK-Thr172 (p-AMPK) expression [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Skeletal muscle glucose transporter type 4 (GLUT 4) expression [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Glycated hemoglobin (HbA1c) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Insulin sensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Lipid profile [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Energy expenditure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Physical activity level [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Abdominal adipose tissue distribution [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Skeletal muscle fibre type composition [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Renal function [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Serum creatinine

  • Liver function [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Transaminases


Enrollment: 10
Study Start Date: December 2008
Study Completion Date: March 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resveratrol
Trans-resveratrol extract from Polygonum Cuspidatum (Mega Resveratrol, Danbury, USA) was used in the trial.Following the run-in period, subjects who were tolerant of the placebo would proceed to the treatment period. Subjects were given a starting dose of 500 mg daily of either resveratrol.The dose was 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. Subjects were instructed to abstain from foods with high resveratrol content during the entire duration of the trial.
Drug: Trans-resveratrol extract from Polygonum Cuspidatum
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 Name: Mega Resveratrol, Danbury, USA
Placebo Comparator: Placebo
All subjects underwent a 2-week run-in period during which placebo was administered. The placebo was manufactured so that it was not distinguishable by color, form, or taste from the active drug. Following the run-in period, subjects who were tolerant of the placebo would proceed to the treatment period. Subjects were given a starting dose of 500 mg daily of matching placebo and instructed to abstain from foods with high resveratrol content during the entire duration of the trial. The dose was 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.
Drug: Placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 69 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ability to give informed consent
  2. Chinese Male
  3. Age 40 to 69 yrs old
  4. 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677611

Locations
Singapore
Alexandra Health, Khoo Teck Puat Hospital
Singapore, Singapore, 768828
Sponsors and Collaborators
Khoo Teck Puat Hospital
National Medical Research Council (NMRC), Singapore
Investigators
Principal Investigator: Kian Peng Goh, FRCP Alexandra Health, Khoo Teck Puat Hospital
  More Information

Publications:
Responsible Party: Kian Peng Goh, Consultant, Khoo Teck Puat Hospital
ClinicalTrials.gov Identifier: NCT01677611     History of Changes
Other Study ID Numbers: NIG 35
Study First Received: August 30, 2012
Last Updated: August 31, 2012
Health Authority: Singapore: Health Sciences Authority, Ministry of Health

Keywords provided by Khoo Teck Puat Hospital:
Resveratrol
SIRT1
AMPK

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014