Research Bites—March 2011

| March 18, 2011

Information provided by www.clinicialtrials.gov

Impact of Bariatric Surgery on Epicardial Adipose Tissue and on Myocardial Function

Purpose. The effect of bariatric surgery action on adipose tissue distribution, in particular on epicardial adipose tissue (EAT) remains unknown. Whether metabolic improvement is associated with EAT reduction is also unknown.

The researchers investigated the effect of bariatric surgery on EAT in patients with severe obesity. The primary endpoint of this study was the change in EAT amount six months after bariatric surgery.

Primary Outcome Measures. Evaluation of three parameters [Time Frame: 36 months] [ Designated as safety issue: No]
1.    To evaluate the variation in myocardial triglyceride content.
2.    To evaluate the variation in left ventricular function or myocardial function.
3.    To describe the relationships between changes in visceral abdominal fat, subcutaneous fat and epicardial fat.

Sponsor. Assistance Publique Hopitaux De Marseille
Information provided by. Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov identifier. NCT01284816

Effect of Bariatric Surgery on Mechanisms of Type 2 Diabetes (Stampede II)

Purpose. The purpose of this study is to determine the effects of bariatric surgery on blood sugar control and underlying mechanisms that contribute to type 2 diabetes mellitus (T2DM) in men and women with a body mass index (BMI) between 27 and 42kg/m2. Sixty subjects will be randomized to either undergo the Roux-en-Y gastric bypass (RYGB) operation or intensive medical, dietary and exercise management.

Primary Outcome Measures. Test the effect of gastric bypass surgery on glycemic control in patients with obesity and T2DM [Time Frame: 12 months] [Designated as safety issue: No]

The working hypothesis for this aim is that patients who are significantly more obese with T2DM who undergo RYGB surgery will achieve glycemic control based on a primary endpoint of an HbA1c ≤ 6.5% at 12 months than patients managed by intensive medical therapy.

Secondary Outcome Measures. Determine the effects of gastric bypass surgery on pancreatic beta cell function and incretin hormone secretion in patients with obesity and T2DM [Time Frame: 12 months] [Designated as safety issue: No]

The working hypothesis for this aim is that a primary physiological link between obesity and T2DM is specific to beta-cell dysfunction; RYGB will reverse beta-cell dysfunction by increasing postprandial incretin secretion.

Sponsor. The Cleveland Clinic
Information provided by. The Cleveland Clinic
ClinicalTrials.gov identifier. NCT01278823

Functional MRI Evaluation of Brain Response to Visual Food Stimulation in Morbidly Obese Patients Before and After Bariatric Surgery

Purpose. To evaluate changes in feeding-related neural activity after different bariatric procedures in patients with morbid obesity. Relationship of gut hormone levels will be assessed as well.

Primary Outcome Measures. Change in neuronal activity response to visual food stimuli after bariatric surgery [Time Frame: Baseline and six months] [Designated as safety issue: No]

Secondary Outcome Measures. Change in circulating blood incretin levels after bariatric surgery [Time Frame: Baseline and six month ] [Designated as safety issue: No]

Difference in measured parameters between sleeve gastrectomy and gastric bypass [Time Frame: Baseline and six months] [Designated as safety issue: No]

Sponsor. Sheba Medical Center
Information provided by. Sheba Medical Center
ClinicalTrials.gov identifier. NCT01140711

Long-limb or Distal Gastric Bypass for Superobesity— Randomized Study

Purpose. The main study objective is to to evaluate long-limb gastric bypass (150cm alimentary limb) versus distal gastric bypass (common channel 150cm) in the treatment of superobesity (BMI 50–60kg/m2).

The main study hypothesis is that the distal bypass procedure accomplishes an estimated 10 to 20 percent more weight loss than long-limb gastric bypass one year after surgery. Patients subject to distal bypass have more gastrointestinal side effects and more extensive nutritional deficiences compared to long-limb gastric bypass.

Primary Outcome Measures. Weight loss [Time Frame: Two and five years postoperatively] [Designated as safety issue: No]

Secondary Outcome Measures. Quality of life, nutritional deficiencies, perioperative outcome, change in comorbidity, short- and long-term complications, health economic considerations, and vitamin and mineral deficiencies [Time Frame: Two and five years postoperative] [Designated as safety issue: Yes]

Sponsor. University Hospital, Aker
Collaborator. The Hospital of Vestfold
Information provided by. Oslo University Hospital
ClinicalTrials.gov identifier. NCT00821197

An Investigation Into Bone Micro-architecture in Women With Type 2 Diabetes

Purpose. Type 2 diabetes mellitus (T2DM) is often associated with health problems, like poor eyesight, muscle coordination, muscle strength, and blood flow. Poor bone health may also be a concern for people with T2DM.

The hypothesis of this study is that bone micro-structure is of poorer quality (reduced trabecular thickness, increased trabecular spacing) in postmenopausal women with T2DM, compared to age-matched control participants.

Primary Outcome Measures. 1 Tesla peripheral magnetic resonace imaging (MRI) assessment at nondominant distal radius [Time Frame: MRI scan complete approximately one month after participant is enrolled] [ Designated as safety issue: No]

Secondary Outcome Measures. Calcium, vitamin D, and vitamin K dietary intakes; TUG (sec); grip strength; DXA assessment of hip, lumbar spine, total body; physical activity [Time Frame: baseline] [Designated as safety issue: No]

Sponsor. Hamilton Health Sciences Corporation
Collaborator. Canadian Institutes of Health Research (CIHR)
Information provided by. McMaster University
ClinicalTrials.gov identifier. NCT00982371

Partners for Better Health in Adolescent Type 2 Diabetes: The Buddy Study

Purpose. To evaluate the effect of a minimally invasive intervention (being assigned a patient partner, or buddy) on blood sugar levels in adolescents with T2DM. also, to assess changes between groups in body weight, number of home glucose monitor checks, adherence to medications, adherence to visit schedule, and psychological well-being.

Eligibility. Adolescents and young adults between 12 and 20 years of age who have been diagnosed with type 2 diabetes and whose blood glucose control needs improvement are eligible for this study.

Design. Participants will be divided by chance into two groups. In one group, participants will have a buddy and receive standard care; while in the other group, participants will receive standard care alone. The buddy is not a health care professional and is not authorized to provide any medical advice.
Participants will be followed in the study for a total of six months. All study participants will receive standard treatment for T2DM.

All patients will be asked to fill out a screening questionnaire (on paper or online) at the beginning of the study and a quality of life and eating behaviors questionnaire at the beginning and at the end of the study. These forms will include questions on medical history, emotions, well being, and eating habits.

Primary Outcome Measures. To evaluate the effect of a minimally invasive intervention (the buddy system) on hemoglobin A1c levels in adolescents with T2DM. [Time Frame: six months] [Designated as safety issue: No]

Secondary Outcome Measures. To assess changes between groups in body weight, number of home glucose monitor checks, adherence to medications, adherence to visit schedule, and psychological well being. [Time Frame: six months] [Designated as safety issue: No]

Sponsor. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by. National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov identifier. NCT01007266

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