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Intra-Abdominal Fat and Risk of Disease in Adolescents

14 Years
18 Years
Not Enrolling
Obesity, Type 2 Diabetes, Cardiovascular Risk, Cancer

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Trial Information

Intra-Abdominal Fat and Risk of Disease in Adolescents

The overall historical goal of this grant has been to examine the determinants of insulin
resistance in children, especially the role of total fat and visceral fat during pubertal
development in "high risk" minority children. Our previous longitudinal work has provided
the platform to propose a new intervention phase of this research. This new emphasis is
justified based on the magnitude of the pediatric obesity problem, particularly in
susceptible ethnic groups, and the need to design and test novel interventions to reduce not
just obesity, but the profound insulin resistance that we have observed in overweight
minority children. Insulin resistance is thought to be central (and perhaps causative) to
several metabolic abnormalities associated with type 2 diabetes and cardiovascular disease.
Thus, interventions aimed at improving insulin resistance in susceptible children could be
an effective means in the primary prevention of type 2 diabetes and cardiovascular disease.

The overall objective of this proposal is therefore to conduct a randomized controlled study
to examine the effects of 16-week exercise and diet interventions on insulin sensitivity,
insulin secretion, beta-cell function, and body fat distribution. Overweight Hispanic boys
and girls (n=80) will be recruited and randomized to one of the following interventions:

Ø Control (delayed intervention) Ø Modification of carbohydrate intake (reduced sugar &
soda, increased fiber & whole grain intake) using an individualized healthy exchange system
and motivational interviewing Ø Strength training + modification of carbohydrate intake Ø
Circuit Training + modification of carbohydrate intake

This study will provide new information on the effects of these interventions on primary
outcomes at the level of body composition (total lean and fat mass, visceral fat,
intramyocellular fat and liver fat) and insulin related measures (insulin secretion &
sensitivity and beta-cell function). The hypotheses are:

1. All interventions will have separate and independent effects on improving insulin

2. Strength training will improve insulin resistance by re-distribution of body fat (lower
visceral fat, intramyocellular lipid and liver fat)

3. Carbohydrate modification will improve insulin secretion and beta-cell function

4. Circuit training will have similar improvements in insulin resistance and have more
improvements on adiposity compared to the strength training group.

5. The aforementioned effects on insulin dynamics will be independent of any effects of
either intervention on weight loss or loss in whole body fat.

The overall rationale for these interventions is based on three main factors. First,
preliminary data are presented in overweight Hispanic boys showing that 16-weeks of strength
training significantly improves insulin sensitivity in the absence of a reduction in total
body fat and in the absence of any dietary intervention. Second, preliminary data suggests
that overweight Hispanic children consume high levels of simple sugar, and low levels of
fiber and complex carbohydrates, and data from the literature suggests that modification of
carbohydrate consumption (reduced sugar, increased fiber & whole grain) can improve glucose
control independent of body composition. Third we provide new preliminary data showing that
the only dietary variable associated with insulin dynamics in overweight Hispanic children
was high sugar intake which was associated with poor beta-cell function.

We have chosen to focus on Hispanic children because they are an understudied, high-risk
population, and display significant obesity-related metabolic abnormalities probably
emanating from profound insulin resistance (see preliminary data). In support of the
feasibility of our proposal, we have developed extensive expertise in recruiting and
retaining research volunteers from the large Hispanic population of East Los Angeles, we
have an experienced multi-disciplinary group of investigators, and the University of
Southern California has the necessary clinical research infrastructure to tackle this
project. If our hypotheses are borne out, it will provide evidence for the incorporation of
strength training and more specific and individualized dietary recommendations in the
prevention and management of obesity, type 2 diabetes, and cardiovascular risk in overweight
Hispanic youth.

Inclusion Criteria:

- Overweight (age- & sex-specific body mass index ≥ 85th percentile based on CDC BMI
growth charts [US Department of Health and Human Services, 2000], calculated by Epi
Info Software, version 3.3)

- Latino (both sets of grandparents must be of Latino heritage as defined by
self-report; limited to Latinos to maintain a homogeneous sample and because Latinos
are at increased risk of insulin resistance and type 2 diabetes.) If the participant
or the parent is unsure of the country of origin of all 4 grandparents they will be
excluded from the study. The participants and their families are not asked whether or
not their grandparents are undocumented immigrants.

Exclusion Criteria:

- Presently taking medication(s) or diagnosed with any syndrome or disease that could
influence dietary intake, exercise ability, body composition and fat distribution, or
insulin action and secretion.

- Previously diagnosed with any major illness since birth (e.g. severe intrauterine
growth retardation, chronic birth asphyxia, cancer).

- Children will not be eligible for participation if they have any diagnostic criteria
for diabetes including polyuria, polydipsia with or without unexplained weight loss,
fasting plasma glucose > 126 mg/dl, or a 2-hour plasma glucose >200 mg/dL during an
oral glucose tolerance test. Children will also be excluded if they test positive for
diabetes-related auto-antibodies, including ICA512 and GAD. Children testing positive
for type 2 diabetes will be referred for treatment. Children with impaired glucose
tolerance (fasting glucose >110 mg/dL or 2-hour glucose >140 mg/dl during an OGTT)
and/or conditions associated with insulin resistance (e.g. acanthosis nigricans,
hypertension, dyslipidemia, PCOS) will be eligible, as long as they are not receiving
treatment and meet other eligibility criteria.

- Participants who are involved in any weight training, exercise, nutrition, or weight
loss program or have been in the past 6 months.

- Participants that do not follow the rules and guidelines of appropriate conduct
during participation, i.e., disruptive behavior, derogatory or racist comments, or
any acts of physical violence towards study staff or other participants, and use of
illegal substances. The principal investigator Dr. Michael Goran will decide if this
conduct warrants exclusion or removal from the study.

- Pregnancy test comes out positive.

- Children who live further than 20 miles away from the General Clinic Research Center

- We can terminate participation if the child fails to follow the rules and guidelines
of appropriate behavior and conduct during participation.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

insulin sensitivity

Outcome Time Frame:

post intervention (week 16)

Safety Issue:


Principal Investigator

Michael I Goran, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California


United States: Federal Government

Study ID:




Start Date:

May 2005

Completion Date:

July 2007

Related Keywords:

  • Obesity
  • Type 2 Diabetes
  • Cardiovascular Risk
  • Cancer
  • Obesity
  • Type 2 Diabetes
  • Cardiovascular risk
  • Cancer
  • Latino
  • Adolescents
  • Strength Training
  • Circuit Training
  • Nutrition
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2
  • Obesity



Veronica Atkins Lifestyle Intervention Laboratory Los Angeles, California  90033-9073