Trial record 37 of 321 for:    metabolic syndrome AND syndrome X AND insulin resistance AND diabetes

Effect of Lycopene and Isoflavones on Glucose Metabolism

This study has suspended participant recruitment.
(FDA needs more information from the manufacturing company of the supplements.)
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT01377961
First received: March 30, 2011
Last updated: December 6, 2011
Last verified: December 2011
  Purpose

Type 2 diabetes mellitus (DM2) is a growing social health problem world-wide, in particular with respect to its contribution to cardiovascular disease. The progressive increase in prevalence of DM2 has reached epidemic proportion and is a major cause of morbidity and mortality in all populations around the world. Conventional stepwise treatment of DM2 generally focuses on controlling blood glucose concentration. However, the risk for side-effects associated with the use of pharmacological intervention often delays initiation of therapy, with the potential implication on worsening morbidity and mortality from complications. On the other hand, non-pharmacological intervention in the form of dietary restrictions, exercise and weight loss, is safe but often difficult to accomplish. The availability of nutrients that affect glucose and lipid metabolism would provide an important practical tool to establish early intervention in newly diagnosed DM2 and perhaps even in patients who are only "at risk" for DM2. The investigators have recently obtained preliminary data on beneficial effects of combined supplementation of lycopene and isoflavones on glucose metabolism of normoglycemic volunteers with insulin resistance. This clinical trial will explore the role of isoflavones and lycopene dietary supplementation in the improvement of glucose metabolism of patients at increased risk or with established but mild DM2. The overall hypothesis is that supplementation of laflavon, provided as a new formulation that increases bioavailability of the individual components (Laflavon CamMedica contains 7 mg of Lycopene and 50 mg of Soy Isoflavones), determines improvement in glucose tolerance and insulin resistance of patients with the metabolic syndrome and also reduces HbA1c in patients with mild DM2.


Condition Intervention
Metabolic Syndrome
Diabetes Mellitus, Non-Insulin-Dependent
Dietary Supplement: Randomized pills either containing combination of lycopene and isoflavones or Placebo to be taken for 12 weeks
Other: Screening
Other: OGTT
Other: Measurements of height, weight, hip, waist and Blood Pressure
Other: Blood Drawing through Venipuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Lycopene and Isoflavones on Glucose Metabolism

Resource links provided by NLM:


Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • Insulin Resistance [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    For Arm 1:Assessment of the Changes in the insulin resistance from baseline to 12 weeks.

  • A1C [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    For Arm 2:Assessment of the Changes in the A1C from baseline to 12 weeks.


Secondary Outcome Measures:
  • For Arm 1 :AUCglucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    For Arm 1: Changes of AUCglucose from baseline to 12 weeks.

  • For Arm1 and Arm 2: The secondary outcome measure are Plasma Lipids concentrations [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    For Arm 2: Changes in the Plasma Lipids concentrations,BMI,Plasma lycopene and isoflavones, EPCs count and function, Chlamydia Trachomatis titers in serum from baseline to 12 weeks.

  • For Arm 1 :AUCglucose,Plasma Lipids concentrations,BMI,Plasma lycopene and isoflavones concentration,EPCs count and function,Chlamydia Trachomatis titers in serum [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    For Arm 1: Changes of AUCglucose,Plasma Lipids concentrations,BMI,Plasma lycopene and isoflavones,EPCs count and function,Chlamydia Trachomatis titers in serum from baseline to 12 weeks.


Estimated Enrollment: 450
Study Start Date: September 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm1: Metabolic Syndrome Volunteers Dietary Supplement: Randomized pills either containing combination of lycopene and isoflavones or Placebo to be taken for 12 weeks

After the screening and OGTT, the treatment group each subject will be in is decided by randomization. Neither subject nor the researchers will be allowed to choose which group a subject is assigned to. A single patient/subject cannot be assigned more than 1 allocation number. Each subject will be assigned randomly (like drawing straws) to receive either on the pills containing the combination of 6mg lycopene and 50mg isoflavones or placebo. Each subject has a 1 in 2 chance of receiving one of these treatments.

The subject are advised to take one capsule of Laflavon/Placebo by mouth daily for 12 weeks.

Other: Screening
Volunteer will be screened as an out patient with a history, physical examination, baseline fasting plasma glucose or A1C, creatinine, AST/ALT, TSH. We may utilize the lab results of the subject available upto 3months prior to the consent date. Pregnancy tests will be performed for female candidates. Information of the level of physical activity, diet, supplements and medications will be obtained.
Other: OGTT
OGTT will be done after the screening at Baseline and at the completion of the 12 weeks of taking the supplements by the subject.
Other: Measurements of height, weight, hip, waist and Blood Pressure
Measurements of height, weight, hip, waist and Blood Pressure are done before and after 12 weeks of taking the supplements.
Other: Blood Drawing through Venipuncture
The blood will be drawn at the baseline and at the completion of the 12 weeks of taking the capsules of laflavon /placebo.
Active Comparator: Arm 2:Previously Diagnosed diabetic patients Dietary Supplement: Randomized pills either containing combination of lycopene and isoflavones or Placebo to be taken for 12 weeks

After the screening and OGTT, the treatment group each subject will be in is decided by randomization. Neither subject nor the researchers will be allowed to choose which group a subject is assigned to. A single patient/subject cannot be assigned more than 1 allocation number. Each subject will be assigned randomly (like drawing straws) to receive either on the pills containing the combination of 6mg lycopene and 50mg isoflavones or placebo. Each subject has a 1 in 2 chance of receiving one of these treatments.

The subject are advised to take one capsule of Laflavon/Placebo by mouth daily for 12 weeks.

Other: Screening
Volunteer will be screened as an out patient with a history, physical examination, baseline fasting plasma glucose or A1C, creatinine, AST/ALT, TSH. We may utilize the lab results of the subject available upto 3months prior to the consent date. Pregnancy tests will be performed for female candidates. Information of the level of physical activity, diet, supplements and medications will be obtained.
Other: Measurements of height, weight, hip, waist and Blood Pressure
Measurements of height, weight, hip, waist and Blood Pressure are done before and after 12 weeks of taking the supplements.
Other: Screening
Volunteer will be screened as an out patient with a history, physical examination, baseline fasting plasma glucose or A1C, creatinine, AST/ALT, TSH. We may utilize the lab results of the subject available upto 3months prior to the consent date. Pregnancy tests will be performed for female candidates. Information of the level of physical activity, diet, supplements and medications will be obtained.
Other: Blood Drawing through Venipuncture
The blood will be drawn at the baseline and at the completion of the 12 weeks of taking the capsules of laflavon /placebo.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Study group 1( arm 1 ::metabolic syndrome group).

Inclusion criteria:

  • Age 18-75 years
  • Metabolic Syndrome (IDF criteria)
  • Stable dose of medications for > 90 days

Exclusion criteria:

  • Pharmacological therapy for diabetes
  • Flood allergies, especially to Whey protein, soy or tomato.
  • Pregnancy

Study group 2( Arm 2:: Diabetes mellitus patients group).

Inclusion criteria:

  • 18-75 years of age
  • Type 2 diabetes (diagnosed with ADA criteria: fasting plasma glucose > 125 mg/dL)
  • Stable dose of medications for > 90 days
  • Patients on diet/exercise, metformin, DD4 inhibitors (sitagliptin and saxagliptin) and /or sulphonylurea for > 90 days

Exclusion criteria:

  • HbA1c above 9.5% or below 7.5% in last 3 months
  • TZD therapy for diabetes
  • Insulin therapy for diabetes
  • Flood allergies, especially to Whey protein, soy or tomato
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377961

Locations
United States, Texas
Stark Diabetes Center Clinic
Galveston, Texas, United States, 77550
Internal Medicine
Galveston, Texas, United States, 77550
Sponsors and Collaborators
The University of Texas, Galveston
Investigators
Principal Investigator: Nicola Abate, MD UTMB
  More Information

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT01377961     History of Changes
Other Study ID Numbers: 10-065
Study First Received: March 30, 2011
Last Updated: December 6, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Insulin Resistance
Endocrine System Diseases
Hyperinsulinism
Lycopene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014