Clinical trial NCT01377961: Effect of Lycopene and Isoflavones on Glucose Metabolism
Official title: Effect of Lycopene and Isoflavones on Glucose Metabolism
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Metabolic Syndrome
Diabetes Mellitus, Non-Insulin-Dependent
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2011-06-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Insulin Resistance
timeFrame: 12 weeks
measure: A1C
timeFrame: 12 weeks
Secondary outcomes:
measure: For Arm 1 :AUCglucose
timeFrame: 12 weeks
measure: For Arm1 and Arm 2: The secondary outcome measure are Plasma Lipids concentrations
timeFrame: 12 weeks
measure: For Arm 1 :AUCglucose,Plasma Lipids concentrations,BMI,Plasma lycopene and isoflavones concentration,EPCs count and function,Chlamydia Trachomatis titers in serum
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Galveston
country: United States
facility: Internal Medicine
state: Texas
city: Galveston
country: United States
facility: Stark Diabetes Center Clinic
state: Texas
Study officials:
affiliation: UTMB
name: Nicola Abate, MD
role: PRINCIPAL_INVESTIGATOR
References: