Hypothalamic Functional Magnetic Resonance Imaging (fMRI) Response to Nutrients

NCT00686608 | Completed Phase 2

• 2 other identifiers: eIRB #938791
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to identify how certain parts of the brain that control appetite respond to changes in dietary carbohydrate and fat.

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

• The primary outcomes of this aim will be the change in fMRI response in the hypothalamus to IV glucose, to IV glucose during intralipid infusion, and to the IV glucose alone, in the lean and obese groups separately.

  0,1,2 and 3 months

Study Arms (3)

Glucose

EXPERIMENTAL

IV glucose

Dietary Supplement: glucose

Fructose

ACTIVE COMPARATOR

Dietary Supplement: fructose

Saline

PLACEBO COMPARATOR

Dietary Supplement: saline

Interventions

glucose DIETARY_SUPPLEMENT

0.3mg/kg of glucose

Glucose

fructose DIETARY_SUPPLEMENT

fructose IV bolus

Fructose

saline DIETARY_SUPPLEMENT

IV saline

Saline

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 year to 45 years of age
• BMI 18 to 25 kg/m2 (25 subjects) and 30 to 40 kg/m2 (25 subjects), matched for age and sex.
• At maximal lifetime weight.
• Weight stable for at least 3 months.

You may not qualify if:

• Those with a major medical illness or who require prescription medication, including: cancer, coronary artery disease, hypertension, and diabetes.
• Subjects taking psychiatric or centrally-acting (CNS) medications, or who are diagnosed with a psychiatric or neurological illness, including: depression, anorexia, bulimia, and seizure disorder.
• Subjects who have lost weight as a result of dieting, pharmacological treatment, or bariatric surgery.
• Weight \> 350 lbs or girth \> 60 inches (the limits of the MR machine)
• Exercise \> 30 minutes, 3 times a week.
• Alcohol consumption \> 2 drinks / day.
• Weight \> 300 lbs (150 kg) (weight limit for MR machine).
• Blood glucose \> 100 mg/dL, abnormal creatinine or liver function tests.
• Illicit drug use.
• Pregnancy.
• Extreme dietary habits as determined by a GCRC nutritionist: very high or low dietary carbohydrate, protein, or fat intakes.
• Those with a contraindication to exposure to strong magnetic fields: presence of metal in the body such as body piercing, shrapnel, cardiac pacemakers or aneurysm clips.
• Those with claustrophobia.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Glucose; Fructose; Sodium Chloride

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jonathan Q. Purnell, M.D.

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will receive infusions of glucose, fructose, and saline in a randomized order.

Study Record Dates

• First Submitted: May 28, 2008
• First Posted: May 30, 2008
• Study Start: October 1, 2006
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2015
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

US (1)