Efficacy and Safety of Nutraceuticals in Patients With Diabetes Mellitus Type II and Dyslipidemia.

NCT03676309 | Completed Phase 2

• 1 other identifier: PON03PE_00078_2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The presence of dyslipidemia, is a significant cardiovascular risk factor. This factor, however, determines the three-fold increase in cardiometabolic risk when an isolated or mixed dyslipidemia is associated with the presence of diabetes mellitus. Diabetes mellitus is a metabolic alteration resulting in a decrease in insulin secondary to reduced availability of this hormone or an impediment to its normal action or a combination of these factors. . Under normal conditions, the vascular endothelium responds to short-term increases in flow by releasing NO and other endothelium-dependent relaxing factors that dilate the artery. Flow-mediated dilation(FMD) is impaired in atherosclerotic coronary arteries. The supplementation with polyphenols of olive leaves, bergamot extract, gymnema sylvatic extract (gymnemic acid) and phaseolamin (bean protein) significantly improves the glico-lipid balance through an improvement in liver function, an inhibition to more levels of lipid metabolism . Recently, it has been documented how the polyphenolic fraction extracted from bergamot (BPF) administered orally both in animal models with induced hyperlipidemia diet, and in patients with metabolic syndrome, produces a significant and substantial reduction of serum cholesterol, triglycerides and blood levels of glucose. This effect was accompanied by an important improvement in vascular reactivity in patients with hyperlipidemia and high blood sugar, suggesting the potential protective role of BPF in patients with metabolic syndrome and elevated cardiovascular risk. Oleuropeina (Olea Europaea) is also characterized by a peculiar polyphenolic profile. Both fruits and leaves, thanks to their cardioprotective activity, are used as antihypertensive agents and in the treatment of vascular disorders. The gymnemic acid (glycosidic triterpene), extracted from the leaves of Gymnema Sylvestre, is the representative element of the plant. Thanks to its presence in the phytocomplex, it carries out a hypoglycaemic action through two main mechanisms: inhibition of intestinal sugar absorption and increased metabolic transformation of glucose at the cellular level. To better define the interrelations of systemic CRFs, FMD, and effects of chronic nutraceutical supplements we performed clinical evaluations and ultrasound measurements of the flow and diameter responses to forearm cuff occlusion in a large, well characterized community-based cohort.

Conditions

Diabetes Mellitus, Type 2; Nutritional and Metabolic Diseases; Vascular System Injury; Therapy-Related Morphologic Change

Outcome Measures

Primary Outcomes (1)

• colesterol

  change cholesterol,

  "day 0" , "month 1", "month 3"

Secondary Outcomes (2)

• Endothelial function

  "day 0" , "month 3"

• Endothelial function

  "day 0" , "month 3"

Study Arms (2)

placebo

PLACEBO COMPARATOR

placebo tablet twice a day twenty minutes before main meals, for 12 weeks,

Drug: Placebo Oral Tablet

nutraceutical oral capsule

ACTIVE COMPARATOR

nutraceutical oral capsule 920 mg twice a day for 12 weeks

Drug: Nutriceutical Oral Capsule,

Interventions

Nutriceutical Oral Capsule, DRUG

nutraceutical 920 mg (Bergamot 450 mg, Gymnema (400 mg, Phaseolamine 30 mg, Olea Europaea 10 mg) twice day , 12 weeks

nutraceutical oral capsule

Placebo Oral Tablet DRUG

placebo tablet twice a day twenty minutes before main meals, for 12 weeks,

Also known as: placebo tablet

placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent signed by the patient
• Fasting plasma glucose ≥ 126 mg / dl (7 mmol / l);
• Hypercholesterolemia (LDL cholesterol ≥ 130 mg / dl), with or without hypertriglyceridemia (\> 175 mg / dl);
• Medical therapy stabilized for 4 months. For women of reproductive age, enrolled in the study, the non-occurrence of pregnancy must be guaranteed.
• All concomitant treatments should have started at least 3 months before the start of the study and should be kept at a constant dose throughout the study.

You may not qualify if:

• Positive pregnancy test (βGCH), made at the selection visit (SEL) or in any case doubtful, pregnant women, lactating women, women of childbearing age who do not use estrogens or progestogens or intrauterine contraceptive methods;
• Patients with severe gastrointestinal disorders with possible influence of the drug on electrolytes and absorption;
• Patients with severe kidney disease (GFR 30 mL / min / 1.73 m2),
• Patients with liver disease or obstructive disorders of the biliary tract, with or without complications (chronic hepatitis, cirrhosis, etc.), or with GOT or GPT at the upper limits of 3 times the laboratory reference values;
• History of alcoholism or drug abuse;
• Clinical history of serious illness that can in some way interfere with the conduct of the study, infections and neoplasms;
• History of psychiatric disorders, major depression, or suicide attempts;
• Patients with HIV or taking HIV medications
• Presence of low-threshold myocardial ischemia
• Presence of heart failure of class III and IV NYHA (New York Heart Association)
• Patients with current infections
• Valve prosthesis patients;
• Patient with atrial fibrillation;
• Patients with contraindication to physical exercise;

Sponsors & Collaborators

• Villa dei Gerani: lead
• University Magna Graecia: collaborator

Study Sites (1)

Capomolla Antonio

Monterosso Calabro, VV, 89819, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Nutritional and Metabolic Diseases; Vascular System Injuries

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Capomolla Antonio, MD

  Villa dei Gerani

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Director

Model Details: Experimental drawing Phase II prospective, randomized, comparative, vs placebo study

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 18, 2018
• Study Start: September 1, 2017
• Primary Completion: March 26, 2018
• Study Completion: March 26, 2018
• Last Updated: September 18, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)