Clinical trial NCT00726908: Intramuscular Lipid and Insulin Action:Ethnic Aspects
Official title: Intramuscular Lipid and Insulin Action:Ethnic Aspects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
diet
carbohydrate
insulin
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-08-01
Enrollment: 69
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: High levels of the hormone insulin are associated with risk for heart disease and diabetes, and may make it hard to lose weight. The types of food eaten may affect insulin levels. The purpose of this study is to determine if manipulation of dietary carbohydrate content improves insulin sensitivity (Si), augments weight loss, and promotes weight loss maintenance in healthy adults.


Eligibility criteria: Inclusion Criteria:

Overweight, age 21-50 years,Women must be premenopausal, Normal glucose tolerance, weight stable for at least 6 months with a weight change no greater than 5 lbs.

Exclusion Criteria:

Exclusion criteria were type 1 or type 2 diabetes, polycystic ovarian disease, BMI \<26.5 or weight \>300 pounds, weight change \>5 pounds in last 6 months, regular exercise \>2 hours per week, pregnancy, currently breastfeeding, cholesterol medications, any disorders of glucose or lipid metabolism, use of medication that could affect body composition or glucose metabolism (including oral contraceptives and blood pressure medications), current use of tobacco, use of illegal drugs in last 6 months, history of hypoglycemic episodes, major food allergies or food dislikes, women with inconsistent or absence of monthly menstrual cycles, and a medical history that counter-indicated inclusion in the study.

Primary outcomes:
measure: Insulin sensitivity
timeFrame: IVGTT and minimal model
Secondary outcomes:
measure: Weight loss
timeFrame: Weight loss over 8 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: Univ. Alabama Birmingham
name: Barbara A Gower, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morrison SA, Goss AM, Azziz R, Raju DA, Gower BA. Peri-muscular adipose tissue may play a unique role in determining insulin sensitivity/resistance in women with polycystic ovary syndrome. Hum Reprod. 2017 Jan;32(1):185-192. doi: 10.1093/humrep/dew279. Epub 2016 Nov 8.
citation: Gower BA, Goss AM. A lower-carbohydrate, higher-fat diet reduces abdominal and intermuscular fat and increases insulin sensitivity in adults at risk of type 2 diabetes. J Nutr. 2015 Jan;145(1):177S-83S. doi: 10.3945/jn.114.195065. Epub 2014 Dec 3.
citation: Gower BA, Pollock NK, Casazza K, Clemens TL, Goree LL, Granger WM. Associations of total and undercarboxylated osteocalcin with peripheral and hepatic insulin sensitivity and beta-cell function in overweight adults. J Clin Endocrinol Metab. 2013 Jul;98(7):E1173-80. doi: 10.1210/jc.2013-1203. Epub 2013 Apr 24.
citation: Ellis AC, Casazza K, Chandler-Laney P, Gower BA. Higher postprandial serum ghrelin among African-American girls before puberty. J Pediatr Endocrinol Metab. 2012;25(7-8):691-6. doi: 10.1515/jpem-2012-0081.
citation: Ellis AC, Chandler-Laney P, Casazza K, Goree LL, Gower BA. Effects of habitual diet on ethnic differences in serum total ghrelin. Endocrine. 2012 Oct;42(2):359-65. doi: 10.1007/s12020-012-9667-2. Epub 2012 Apr 7.
citation: Goree LL, Chandler-Laney P, Ellis AC, Casazza K, Granger WM, Gower BA. Dietary macronutrient composition affects beta cell responsiveness but not insulin sensitivity. Am J Clin Nutr. 2011 Jul;94(1):120-7. doi: 10.3945/ajcn.110.002162. Epub 2011 May 18.