Glycemic Load & Resistance Training on Endothelial Function & Insulin Sensitivity

160 Participants Aged 18-35 Years and Obese (BMI =30) Open to Men and Women of All Ethnicity Clinical Trial

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Official title:

Glycemic Load & Resistance Training on Endothelial Function & Insulin Sensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755962
• Other study ID #: 546464
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: December 14, 2017

Study information

• Verified date: November 2020
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project is prompted by the urgent public health need to identify novel strategies to prevent cardiovascular disease (CVD) and type 2 diabetes (T2D). The higher prevalence of CVD, T2D, and metabolic syndrome in obese individuals is a major healthcare concern. Therefore, finding optimal intervention strategies to combat these growing epidemics is imperative.

Description:

At present, the extent to which dietary components can modify endothelial function, monocyte inflammation and glycemic variations is not well defined, although different carbohydrates are known to vary in their abilities to induce plasma glucose and insulin responses. Epidemiologic work suggests that high dietary glycemic load (GL) is associated with increased concentrations of inflammatory cytokines, endothelial dysfunction markers, and increased risk of T2D and coronary heart disease (CHD). We are examining using randomized control trials low vs. high-GL diet to determine if low-GL diets induce improvements in endothelial function or monocyte inflammation. Furthermore, resistance training is an alternate form of exercise from conventional aerobic training. Resistance Training has the potential to improve endothelial function or monocyte phenotype, but there is very little data in this area. We hypothesize that resistance training may augment the beneficial effects of a low-GL diet in improving metabolic health.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 14, 2017
• Est. primary completion date: December 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• 18-35 with BMI=30 and/or your waist circumference =40 inches for males or =35 inches for females

• In good health as determined by the screening visit and review of medical history

Exclusion Criteria:

• Have a known heart arrhythmia and/or abnormalities found in electrocardiogram (ECG) reading or use of medications that influence CV function

• Have been in a weight loss or exercise program in the 6 months prior to participation

• Use tobacco products

• Have a syndrome or are prescribed medications that may influence body composition, insulin action, or CVD (e.g. PCOS, prednisone, methylphenidate, etc.)

• Have intolerance to lactose or gluten

• Pregnant

Related Conditions & MeSH terms

• 160 Participants Aged 18-35 Years and Obese (BMI =30) Open to Men and Women of All Ethnicity
• Insulin Resistance

Intervention

Other:
• Glycemic Load

• Resistance Training

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	body composition (total fat mass, visceral fat, HFF, LBM) via DXA and MRI		12 weeks
Other	plasma and cellular biomarkers post pre and post 12 week intervention	Monocytes will be isolated from subject whole blood and will be phenotyped in 2 ways: 1) as pro- or anti-inflammatory based on flow-activated cell sorting (FACS) analysis of monocyte-specific markers TLR-4, CD14 and CD16.; Serum-Stimulated Cell Culture. Subject serum will be incubated with L6 cells as we have previously performed in monocytes and adipocytes as well as endothelial cells 18, 130. Following 48 hr incubation, cellular insulin-stimulated glucose transport will be assayed as described 129 and conditioned medium assayed for myokine levels (ex. IL-15, 1L-6, etc).; Fasting plasma (and conditioned media where appropriate) will be taken to determine a panel of adipokines and hormones (e.g. insulin, adiponectin, HSP-72, IL-4, IL-6, IL-10, MCP-1, CRP, 8-iso PGF2a) will be measured using the Millipore Multiplex assay kit or with specific ELISA kits	12 weeks
Other	RNA/protein levels via muscle and fat tissue collection	Approximately 300 mg of muscle tissue from the superficial portion of the vastus lateralis and approximately 3-5 g of subcutaneous adipose tissue from the periumbilical portion of the abdomen will be obtained.	12 weeks
Primary	Endothelial function as determined by brachial artery FMD		12 weeks
Secondary	monocyte inflammation		12 weeks
Secondary	Insulin Sensitivity by Oral Glucose Tolerance Test		12 weeks
Secondary	MAGE via Continuous Glucose Monitoring System		12 weeks