Expired Study
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Aurora, Colorado 80045


Purpose:

The goal of this proof of concept/feasibility study is to use rigorous methodology to explore links between daytime energy status and nocturnal fat metabolism in healthy adults.


Study summary:

This primary goal of this pilot project is to obtain preliminary data demonstrating the feasibility of measuring lipolysis and fat oxidation during sleep in adult human subjects using microdialysis, stable isotope labeling techniques, and whole-room indirect calorimetry. The results of this study will be used in grant applications to perform definitive studies using these methods. The long term goal of this line of research is to explore the mechanisms responsible for sex based differences in the effectiveness of physical activity as an approach to weight loss. Previous longitudinal data have shown that in normal weight and obese individuals, for any given increase in physical activity, there is a significantly greater loss of fat mass in men relative to women [Westerterp, 1997]. These data need to be reconciled, however, with the wealth of data demonstrating that during exercise, women release and oxidize fat more readily than men [Horton, 2009; Horton 1998, Moro 2007]. This phenomenon seems counterintuitive, given that men have less body fat than women and are able to lose more body fat than women when beginning a weight loss program [Bjorntorp, 2007]. Recent data suggests a mechanism to explain this paradox. Specifically, in obese subjects, 24-hour fat oxidation increased following a daytime bout of exercise, and this increase occurred in men only and was driven by a significant increase in fat oxidation not during the day but rather during sleep the night following exercise [Bergouignan, 2014]. Since the predominant source of fuel during sleep is free fatty acids (FFA) released from adipose tissue (i.e., lipolysis), it may be that enhanced sleeping lipolysis is a key factor in how exercise stimulates fat oxidation and thus greater fat loss in males vs. females over time. The primary objective of the proposed study is to demonstrate the feasibility of measuring nocturnal whole-body and regional lipolysis by using stable isotope techniques and microdialysis of subcutaneous abdominal adipose tissue respectively with the long term goal of determining the effects of acute exercise during the daytime on rates of lipolysis at night in men and women. A secondary objective of this study is to determine if nocturnal regional lipolysis measured by microdialysis of subcutaneous abdominal adipose tissue and whole body lipolysis measured by a stable glycerol isotope infusion are related to dietary and whole body fat oxidation measured by stable isotope labelled fatty acid and whole-room calorimetry, respectively. Finally, the study aims to determine if sleep quality parameters measured by EEG and wrist actigraphy correlate with measures of nocturnal fat oxidation and lipolysis (regional and whole body)


Criteria:

Inclusion Criteria: - Males and Females, 20-35 years of age - Sedentary (planned exercise < 3 d/week, < 30 min/session) - Lifetime maximum BMI of 30 kg/m2 - Weight stable by self-report for at least 2 mo before the study (<5% weight change) - Habitual sleeping pattern of >7 hours not to exceed 9.25 hours of sleep per night - Zero to low-moderate caffeine intake (not to exceed 500 mg/d) - Alcohol use fewer than two standard drinks per day per week for males and one or less drinks per day per week for females. Exclusion Criteria: - Current smoker - Use of any medication that could affect lipid metabolism, insulin signaling, or sleep - Pregnant women will not be enrolled in the study - Current or chronic medical/psychiatric conditions - Shift work or dwelling below Denver altitude (1,600 m) a year prior to testing - Travel across more than one time zone 3 wk before study - Abnormal eating patterns identified by interview and eating questionnaire - Screening positive for illicit drugs - Chronic health conditions such as diabetes, - Hyper or hypothyroidism - Sleep apnea (Apnea-Hypopnea Index >5) - Renal or liver disease, anemia, or cancer - Regularly go to sleep after midnight - One or more of the following out-of-range values measured on a fasting blood sample: - glucose > 110 mg/dl, - thyroid stimulating hormone <0.5 or >5.0 uU/ml, - hemoglobin < 14.5 g/dl men, <12.3 g/dl women, - alanine amino transferase > 47 U/l, - aspartate aminotransferase > 47 U/l, - alkaline phosphatase <39 or >117 U/l, or - creatinine >1.1 mg/dl.


Study is Available At:


Original ID:

13-0359


NCT ID:

NCT02408510


Secondary ID:


Study Acronym:


Brief Title:

Pilot Project to Examine the Effects of Exercise on Nocturnal Lipolysis in Men and Women


Official Title:


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

20 Years


Maximum Age:

35 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Colorado, Denver


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

15


Enrollment Type:

Actual


Overall Contact Information

Official Name:Daniel Bessesen, MD
Principal Investigator
University of Colorado, Denver

Study Dates

Start Date:August 2015
Completion Date:September 2017
Completion Type:Actual
Primary Completion Date:September 2017
Primary Completion Type:Actual
Verification Date:June 2019
Last Changed Date:June 27, 2019
First Received Date:March 30, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change in Lipolytic Hormones
Time Frame:Overnight (2200h-0700h)
Safety Issues:False
Description:Frequent blood sampling to measure growth hormone, cortisol, catecholamines, and other lipolytic hormones
Outcome Type:Secondary Outcome
Measure:Change in Sleep Quality
Time Frame:Overnight (2200h-0700h)
Safety Issues:False
Description:Measured using wrist actigraphy
Outcome Type:Primary Outcome
Measure:Change in Substrate Oxidation
Time Frame:24 hours
Safety Issues:False
Description:Measured using whole-room calorimetry
Outcome Type:Primary Outcome
Measure:Change in Lipolysis
Time Frame:Overnight (2200h-0700h)
Safety Issues:False
Description:Measured using stable isotope tracers and microdialysis

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Colorado, Denver

Samples and Retentions

Study Population: Healthy Adults
Sample Method:Non-Probability Sample

Study References

Reference Type:Reference
Citation:Bergouignan A, Kealey EH, Schmidt SL, Jackman MR, Bessesen DH. Twenty-four hour total and dietary fat oxidation in lean, obese and reduced-obese adults with and without a bout of exercise. PLoS One. 2014 Apr 8;9(4):e94181. doi: 10.1371/journal.pone.0094181. eCollection 2014.
PMID:24714529
Reference Type:Reference
Citation:Björntorp PA. Sex differences in the regulation of energy balance with exercise. Am J Clin Nutr. 1989 May;49(5 Suppl):958-61. doi: 10.1093/ajcn/49.5.958. Review.
PMID:2655420
Reference Type:Reference
Citation:Moro C, Pillard F, de Glisezinski I, Crampes F, Thalamas C, Harant I, Marques MA, Lafontan M, Berlan M. Sex differences in lipolysis-regulating mechanisms in overweight subjects: effect of exercise intensity. Obesity (Silver Spring). 2007 Sep;15(9):2245-55.
PMID:17890493
Reference Type:Reference
Citation:Horton TJ, Pagliassotti MJ, Hobbs K, Hill JO. Fuel metabolism in men and women during and after long-duration exercise. J Appl Physiol (1985). 1998 Nov;85(5):1823-32.
PMID:9804587
Reference Type:Reference
Citation:Horton TJ, Dow S, Armstrong M, Donahoo WT. Greater systemic lipolysis in women compared with men during moderate-dose infusion of epinephrine and/or norepinephrine. J Appl Physiol (1985). 2009 Jul;107(1):200-10. doi: 10.1152/japplphysiol.90812.2008. Epub 2009 Apr 30.
PMID:19407251
Reference Type:Reference
Citation:Westerterp KR, Goran MI. Relationship between physical activity related energy expenditure and body composition: a gender difference. Int J Obes Relat Metab Disord. 1997 Mar;21(3):184-8.
PMID:9080256

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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