Metabolic Impact of Fructose Restriction in Obese Children

NCT01200043 | Completed DMC

• 2 other identifiers: UCSF-2845R01DK089216
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The sugar fructose has been implicated not just as a cause of obesity, but as a cause of the metabolic diseases that go along with obesity, termed "metabolic syndrome". Obese children with metabolic disease will be studied before and after 10 days of a fructose restricted diet. The question is whether their co-morbidities will improve, even if weight remains constant.

Conditions

Obesity; Metabolic Syndrome

Keywords

Childhood obesity; metabolic syndrome; insulin resistance; intrahepatic fat; hypertension

Outcome Measures

Primary Outcomes (1)

• intrahepatic fat content

  We anticipate fructose restriction to reduce intrahepatic fat, exclusive of calories

  10 days

Secondary Outcomes (1)

• insulin resistance

  10 days

Study Arms (1)

fructose restriction

EXPERIMENTAL

Isocaloric fructose restricted diet for 10 days

Other: fructose restriction diet

Interventions

fructose restriction diet OTHER

fruits and vegetables only

fructose restriction

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• African-American, Latino, and Caucasian boys and girls. Ethnicity is to be determined by self-report. Utilizing the US Census Bureau procedures, participants will be asked two questions, the first regarding ethnicity and the second on race. Subjects will be given the opportunity to select more than one racial category.
• Ages 8 to 18 yr. The minimum age cutoff is due to our desire not to sedate younger children for the magnetic resonance spectroscopy scan or magnetic resonance scan (MRS, MRI). We chose to study these groups because they are most affected by metabolic syndrome and manifest the greatest morbidities; yet their presentations are different from each other.
• The following criteria are modified from the National Cholesterol Education Program's Adult Treatment Panel and the World Health Organization definition of metabolic syndrome. Waist circumference is not an adequate predictor of visceral adiposity in children. Also, no normative values have been developed nor is this measurement consistent between racial and ethnic groups. Body mass index (BMI), however, correlates strongly with both visceral lipid depot and blood pressure. The definition of hypertension is greater than the 95th percentile for sex and age as designated in the 1996 Task Force Report on High Blood Pressure in Children and Adolescents.
• Obesity, as defined by BMI z-score of 2.0 or greater, or above the 97th percentile for age and sex; and weight ≥40 kg.
• Hyperinsulinemia (fasting insulin \>15 µU/mL), or insulin resistant (HOMA \> 4.3). See details below.
• At least one of the following: systolic blood pressure above the 95th percentile for age and sex, or triglyceride level above the 95th percentile for age, sex and race or ethnic group as established by the 1998 National Heart, Lung, and Blood Institute Growth and Health Study.

You may not qualify if:

• History of disorders other than obesity that may affect insulin levels, such as Cushing's syndrome, diabetes mellitus, or depression.
• Medications that may affect insulin sensitivity or hepatic lipid content, e.g. metformin, steroids, atypical antipsychotics, anti depressants, statins, Vitamin E, thyroid medications, anti-hypertensives, weight loss medications, oral contraceptives.
• Pregnancy or lactation.
• Surgical procedures for obesity.
• History consistent with obstructive sleep apnea.
• Implants including intracranial surgical clips, pacemakers, and other metals or implants that preclude MR scanning.
• Claustrophobia.
• Inability to fit within the MR bore: shoulder to shoulder width of greater than 58 cm or anterior-posterior length greater than 35 cm (magnet bore size limitation).
• Weight greater than 320 pounds (MRS table weight limitation).
• Eating disorders.
• Smoking or alcohol use. Subjects will answer the two questions on the Alcohol Query Form. Any consumption of more than 2 drinks per month will
• Vegan diet.
• All subjects with known diabetes mellitus according to the 1997 ADA criteria will be excluded. However, subjects with known impaired glucose tolerance (fasting glucose 101-125, and 2-hour post-prandial glucose level between 141-200) can remain eligible.
• Syndromic patients (e.g. Prader-Willi, Bardet-Biedl) will be excluded, as it is likely that the reasons for their obesity may be neurologic or single-point mutations, and are likely to be different from those causing the Metabolic Syndrome.
• Subjects who are found to be hypothyroid by clinical exam or by evaluation of thyroid function tests on first visit to the WATCH Clinic will receive L-thyroxine for three months, with documentation of adequate replacement, prior to enrollment in the protocol.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Touro University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

UCSF

San Francisco, California, 94143, United States

Location

Related Publications (2)

• Schwarz JM, Noworolski SM, Erkin-Cakmak A, Korn NJ, Wen MJ, Tai VW, Jones GM, Palii SP, Velasco-Alin M, Pan K, Patterson BW, Gugliucci A, Lustig RH, Mulligan K. Effects of Dietary Fructose Restriction on Liver Fat, De Novo Lipogenesis, and Insulin Kinetics in Children With Obesity. Gastroenterology. 2017 Sep;153(3):743-752. doi: 10.1053/j.gastro.2017.05.043. Epub 2017 Jun 1.

  PMID: 28579536 DERIVED

• Gugliucci A, Lustig RH, Caccavello R, Erkin-Cakmak A, Noworolski SM, Tai VW, Wen MJ, Mulligan K, Schwarz JM. Short-term isocaloric fructose restriction lowers apoC-III levels and yields less atherogenic lipoprotein profiles in children with obesity and metabolic syndrome. Atherosclerosis. 2016 Oct;253:171-177. doi: 10.1016/j.atherosclerosis.2016.06.048. Epub 2016 Jul 19.

  PMID: 27451002 DERIVED

MeSH Terms

Conditions

Obesity; Metabolic Syndrome; Pediatric Obesity; Insulin Resistance; Hypertension

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Robert Lustig, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 13, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 14, 2018

Record last verified: 2018-05

Locations

US (1)