Safety and effectiveness of the BIB® System in conjunction with a behavior modification program compared to the behavior modification program alone for weight loss in obese subjects.

The primary objective of this study is to observe if Sibutramine is effective in improving the symptoms and signs of sleep apnea in obese patients. The secondary objectives are to document the effects of Sibutramine on heart rate variability and 24-h arterial pressure values. We hypothesized that sibutramine will improve sleep disordered breathing, cardiac autonomic function and systemic blood pressure in obese patients with obstructive sleep apnea (OSA).

The purpose of this study is to determine whether a low-fat or low-glycemic load diet is more effective for controlling weight and blood glucose in persons with type 2 diabetes.

The aim of the project is to determine if milk supplementation during a caloric restriction program facilitates the lost of weight, improves the appetite control and attenuates the decrease of bone mineral content in low-calcium consumer women.

The purpose of this study is to determine whether online peer support will increase adherence to an internet-based pedometer walking program.

This trial will be conducted in the United States of America (USA). The aim of this clinical trial is to investigate whether NNC 0070-0002-0349 is safe and well tolerated. Groups of eight subjects will be administered subcutaneous injections of NNC 0070-0002-0349 or placebo on Day 1 beginning with a low dose; after which laboratory and vital sign data as well as subject reported adverse events will be evaluated. If safe to proceed, the next group of subjects will be given a higher dose and the safety evaluation performed again before proceeding. In total, 5 dose levels will be evaluated. Subjects will be administered a dose and remain in the clinic until the morning of Day 8 after dosing and vital signs and safety labs as well as blood drawn for pharmacokinetic samples taken. Subjects will return to the clinic on Days 10, 12, 14, 16, 18 and 22 for repeat blood draws and safety labs. Day 22 is the final study visit.

African-American (AA) individuals are less sensitive to insulin than Caucasian (C ) individuals, a difference that may bear upon the greater prevalence of type 2 diabetes among AA. Lower insulin sensitivity (Si) among AA is independent of body composition, body fat distribution, diet, and physical activity. To date, no explanation has been uncovered for lower Si among AA. The PI's recent research has indicated that intramyocellular (IM) lipid, as estimated using attenuation values from a single-slice computed tomography scan of the quadriceps muscle, is higher among AA vs C postmenopausal women. Accumulation of IM lipid has been associated with impaired Si. The Specific Aims of this proposal are to:

1. Verify, using magnetic resonance spectra, that IM lipid is higher in AA vs C;
2. Determine how IM lipid relates to Si among AA and C subjects.
3. Determine if manipulation of ML via dietary intervention alters Si in healthy AA and C subjects.

A. Quantify ML and Si before and after treatment with a low- vs moderate-fat diet. Preliminary data from the investigative team have shown that a low-fat diet will deplete IMCL. B. Quantify ML and Si before and after treatment with a low- vs moderate-carbohydrate (CHO) diet. Preliminary data from the investigative team have shown that a low CHO diet reduces AIRg. The specific hypotheses to be tested are that:

1. IM lipid will be higher in AA vs C;
2. Greater IM lipid will be associated with lower Si;
3. Greater IM lipid will explain lower Si among AA vs C.
4. A low-fat diet will deplete ML and increase Si among both AA and C.
5. A low-CHO diet will decrease glucose-stimulated insulin secretion, which will result in an increase in adiponectin. The increased adiponectin will lead to an increase in ML oxidation, and a decrease in measured ML; as a result, Si will increase. These effects will be apparent primarily among AA, who have greater first-phase insulin secretion than C.

An innovative dietary approach to obesity, based on the set-point theory of body weight and associative learning, was developed by Seth Roberts. Roberts's approach focuses on dissociating flavor and calories by consuming small amounts of very bland but calorie-dense foods such as extra-light olive oil between meals. Roberts believes that the dissociation between flavor and calories lowers the body weight's set point, suppressing appetite and thereby inducing weight loss without causing hunger. Studying the feasibility of this approach is particularly relevant to patients taking drugs that cause increased appetite and weight gain as a side effect, as increased hunger makes the usual calorie restriction approach even more difficult than it normally is. Low-income people have a diet higher in prepackaged standardized foods, which may be one contributing factor to their higher risk of developing obesity. Specific Aims

• To test the acceptance of, and the patients' compliance rate to, the Shangri-La Diet
• To ascertain whether a controlled clinical trial of the Shangri-La Diet would be feasible.
• To see if the weight loss documented anecdotally in many people is reproducible in patients from low-income areas who are overweight and taking prescribed medications associated with increased appetite and weight gain.

Analysis: The primary end point will be acceptability of the dietary intervention as measured by the final interview and the evaluation form—is this something patients would be willing to do over the long term? This will help determine whether a controlled trial of the dietary intervention would be feasible, and provide information needed to design such a trial. Secondary outcomes will be changes in the participants' weight, waist measurements, anxiety, and depression scores

Prior studies examining the pharmacokinetics, safety, and efficacy of the new etonogestrel-containing single rod implantable contraceptive device, Implanon, did not include women who exceeded 130% of ideal body weight. Yet, as these women comprise a significant portion of the U.S. population, studies of Implanon in obese women are essential. The proposed study represents an important first step in addressing the lack of data on Implanon in obese women. We aim to examine the pharmacokinetics of Implanon in obese women during the first 6 months of use and to provide data on the acceptability, side effect profile, and ease of insertion, palpation, and removal in these women. We also aim to collect samples for future validation studies of the use of the blood spot (finger-stick blood sample on filter paper) as a method of determining plasma etonogestrel.

The purpose of this research study is to evaluate two nutrition and exercise programs in children ages 9-12 who are at risk for developing type 2 diabetes. This study also includes the involvement of parents or guardians who are willing to participate in these programs with the child.