Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02397304
Other study ID # RG_15-036
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 12, 2015
Last updated March 18, 2015
Start date April 2015
Est. completion date April 2016

Study information

Verified date March 2015
Source University of Birmingham
Contact Gareth A Wallis, PhD
Phone 0121 414 4129
Email g.a.wallis@bham.ac.uk
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial Summary

Obesity is a major public health issue and its association with insulin resistance greatly increases risks for cardiovascular disease and type 2 diabetes. Exercise training is recommended for obese populations, but longitudinal studies indicate aerobic exercise training in obese individuals in the absence of weight loss has minimal impact on insulin resistance. High turnover of fat stored within muscle cells (i.e., intramyocellular triglyceride) during exercise and elevated muscle fitness (i.e., muscle oxidative capacity) are key features of the enhanced insulin sensitivity observed in endurance-trained individuals. It could be that longitudinal studies of exercise training in obese individuals failed to sufficiently stimulate intramyocellular triglyceride turnover during exercise and muscle oxidative adaptation as a result of failure to consider the impact of recent nutrition within their study designs. Performing exercise in the fed vs. fasted state can blunt these exercise responses in non-obese individuals. The researchers will investigate the hypothesis that an acute bout of aerobic exercise performed in the overnight-fasted versus fed-state can stimulate greater intramyocellular triglyceride utilization during exercise and enhanced expression of genes related to muscle oxidative adaptation in obese individuals. The expected outcomes will help to determine if exercising in the fasted state could be used to optimise metabolic adaptation to training in obese individuals. The future impact of this research could be the recommendation of a simple nutritional strategy considering meal timing to enhance the effects of aerobic exercise training in obese individuals, with potential long-term benefits for reducing insulin resistance and cardio-metabolic disease risk.


Description:

Two thirds of the adult US population is overweight or obese and the prevention and treatment of obesity is a key priority due to the strain on societal health, well-being and economic prosperity. Obesity is associated with insulin resistance characterized by a reduced ability of insulin to stimulate glucose uptake into skeletal muscle and by hyperglycaemia. Obesity and insulin resistance are major risk factors for cardiovascular disease and type 2 diabetes. Weight loss through caloric restriction and increasing physical activity levels are the mainstay of non-surgical/pharmacological treatment for obesity. Weight loss can reduce insulin resistance although sustainable weight loss is difficult to achieve. Physical activity can help with weight maintenance but perhaps surprisingly, carefully controlled longitudinal studies in obese patients indicate aerobic exercise training in the absence of weight loss has no or at best modest impact on peripheral insulin resistance.

One mechanism by which regular aerobic exercise training ensures high peripheral insulin sensitivity in endurance trained individuals is via stimulation of intramyocellular triglyceride turnover and muscle fat oxidation, which maintains low muscle levels of fatty acid metabolites known to interfere with insulin-stimulated muscle glucose uptake (e.g., fatty acyl CoA, diacyglycerols, ceramides). Indirect evidence suggests intramyocellular triglyceride can be utilized as fuel during aerobic exercise in obese individuals, at least in the overnight-fasted state. However, the influence of overnight-fasted vs. fed-state exercise on intramyocellular triglyceride utilization and muscle oxidative adaptation has not been studied in obesity. This is important to study as fed-state exercise, as compared to overnight-fasted exercise, blunts exercise-associated increases in intramyocellular triglyceride utilization, oxidative gene expression, long-term adaptation of muscle oxidative capacity and resistance to high fat diet induced impairments in oral glucose tolerance in lean individuals.

Thus, the presence or timing of recent nutrition with respect to exercise could be a critical factor explaining the inability of aerobic exercise training per se to improve peripheral insulin sensitivity in longitudinal studies in obese populations. Exercising in the overnight-fasted state could optimize metabolic adaptation to training in obese individuals with long-term benefits for reduced insulin resistance and cardio-metabolic disease risk.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 8
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 49 Years
Eligibility - Anthropometry/Body Size:

i. Overweight (White European populations, BMI 25-29.9 kg/m2 or Asian populations, BMI 23-27.4 kg/m2) and have a high waist circumference (European, Sub-Saharan Africans and Eastern Mediterranean and middle east [Arab] men = 94 cm [37 inches], women = 80 cm [31.5 inches]; South Asian, Chinese, Japanese, and ethnic south and central Americans men = 90 cm [35 inches], women = 80 cm [31.5 inches]) or ii. Class I obesity (White European populations, BMI 30-34.9 kg/m2 or Asian populations, BMI 27.5-35 kg/m2).

- Weight stable i.e. (±2 kg) for >3 months before enrolment

- Sedentary i.e. no regular engagement in physical activity

- Diagnosis and general health: Good general health defined as no known cardiovascular or metabolic disease

- Compliance: understands and is willing, able and likely to comply with all study procedures and restrictions

- Consent: demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent.

Exclusion Criteria:

- Answering "YES" to any question on the Screening Form

- Hypertension (=140/90 mmHg)

- Any ECG Abnormalities

- Current participation in another clinical study

- Current or recent smoker (last 30 days)

- Past history of substance abuse, engagement in uncommon eating practices (e.g., sustained periods of fasting) and taking prescription or non-prescription medication (e.g., beta-blockers, insulin or thyroxine) or supplements that may influence normal metabolic responses.

- Participants who have previously (within 5 years of the present study) had 4 or more muscle biopsies obtained from the thigh quadriceps region will be ineligible

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
Exercise
Participants will complete two morning exercise sessions. One will be performed in the overnight fasted-state (i.e. no food or drink, except water, from 10pm the evening before) and the other will be performed in the fed-state having received a breakfast by the research team before exercise.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Birmingham Allen Foundation Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Intramuscular triglyceride use during exercise (arbitrary units) Does exercising in the overnight-fasted state promote greater breakdown of intramuscular fat than performing exercise in the fed state? Up to 12 months No
Secondary Gene expression The influence of pre- versus post-exercise feeding on the expression of genes related to exercise. training adaptation. Accordingly, muscle samples will be analysed using qPCr for expression of genes (relative mRNA) involved in fat metabolism (FAT/CD36, CPT1, ßHAD), mitochondrial biogenesis (PGC-1a) and substrate oxidation (COXIV, CYT C, CS, SDH). Up to 12 months No
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2