Improving Diabetes Through Lifestyle and Surgery

NCT ID: NCT01667783

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-02-28

Brief Summary

Weight loss is effective in reducing many complications of obesity, with the majority of patients who undergo bariatric surgery having substantial improvements in their weight-related illnesses. The investigators propose a pilot study in 45 subjects with mild to moderate obesity to compare how losing 10% of initial body weight via one of three common weight loss strategies (medical weight loss with a low calorie diet, Roux-en-Y gastric bypass surgery, and adjustable gastric banding) affects diabetes. While the investigators do not expect this pilot study to provide definitive answers, it will provide valuable information to design a larger trial which will help guide therapy for people with mild-moderate obesity and substantial comorbidities.

Conditions

Obesity; Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gastric Banding

Laparoscopic Adjustable Gastric Banding

Group Type: ACTIVE_COMPARATOR

Gastric Banding

Intervention Type: PROCEDURE

Laparoscopic Adjustable Gastric Banding using the LapBand

Medical Weight Loss

Medical Weight Loss using a comprehensive lifestyle intervention consisting of diet (meal replacements), physical activity and behavioral techniques

Group Type: ACTIVE_COMPARATOR

Medical Weight Loss

Intervention Type: BEHAVIORAL

Weight loss intervention using diet (meal replacments), physical activity and behavioral techniques administered with weekly one-on-one counselling by dieticians

Gastric Bypass

Roux-en-Y Gastric Bypass

Group Type: ACTIVE_COMPARATOR

Gastric Bypass

Intervention Type: PROCEDURE

Laparoscopic Roux-en-Y Gastric Bypass

Interventions

Gastric Banding

Laparoscopic Adjustable Gastric Banding using the LapBand

Intervention Type: PROCEDURE

Medical Weight Loss

Weight loss intervention using diet (meal replacments), physical activity and behavioral techniques administered with weekly one-on-one counselling by dieticians

Intervention Type: BEHAVIORAL

Gastric Bypass

Laparoscopic Roux-en-Y Gastric Bypass

Intervention Type: PROCEDURE

Other Intervention Names

HMR meal replacements will be used

Eligibility Criteria

Inclusion Criteria

• BMI 30-40 kg/m2 at screening visit 1
• Age 21-64 years
• Insured by collaborating insurance plan (Employee Health Plan)
• Type 2 Diabetes
• Medically safe to undergo surgery and approved by a psychologist
• Able to exercise at a moderate level
• Able to give informed consent
• Willing to accept randomization to each group
• Able to communicate (both written and oral) in English
• Willing to use reliable method of birth control during study and ≥18 months postop (if applicable)

Exclusion Criteria

• Prior bariatric surgery
• Prior gastric, small or large bowel, spleen, pancreas, kidney, or liver surgery, including large ventral hernia or previous large ventral hernia repair.
• Weight loss of ≥ 5% of body weight in the past 6 months
• Uncontrolled diabetes (HbA1c>8.5%)
• Untreated severe diabetic retinopathy
• Use of thiazolidinediones or insulin currently or within the past 3 months
• Uncontrolled blood pressure (>160/100 -may be rescreened)
• Estimated glomerular filtration rate (GFR)<30
• Malignancy (except squamous or basal cell of the skin) in the past 5 years
• MI, stroke or cardiovascular procedure within 12 months
• Known HIV positive or use of anti-HIV therapy (HAART)
• Unstable angina
• Significant pulmonary disease with oxygen dependency
• Chronic use (including in the past 6 months) of medications likely to cause weight gain or prevent weight loss (e.g. corticosteroids, lithium)
• Use of prescription weight loss medication or over-the-counter orlistat in the past 6 months
• Other serious medical condition likely to hinder accurate measurement of weight, or for which weight loss is contraindicated, or which would cause weight loss
• History of severe depression requiring hospitalization in the past 12 months
• Severe mental illness including bipolar disorder, schizophrenia or other psychotic disorders
• Current bulimia nervosa
• Unable or unwilling to use meal replacement products
• Consumption of >14 alcoholic drinks/week or > 5 drinks on more than 2 occasions in the past 12 months
• Use of illicit substances in the past 12 months
• Cigarette or cigar smoking in the past 2 months
• Pregnant or nursing within past 6 months
• Plans to become pregnant within 2 years
• Plans to relocate from the area within 1 year
• Another member of household is a study participant or staff in the trial

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeanne M. Clark, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Countries

United States

References

Varma S, Lee CJ, Brown TT, Maruthur NM, Schweitzer M, Magnuson T, Kamel I, Clark JM. Comparative Effects of Medical Versus Surgical Weight Loss on Body Composition: a Pilot Randomized Trial. Obes Surg. 2019 Aug;29(8):2503-2510. doi: 10.1007/s11695-019-03879-4.

Reference Type: RESULT

PMID: 30997619 (View on PubMed)

Lee CJ, Florea L, Sears CL, Maruthur N, Potter JJ, Schweitzer M, Magnuson T, Clark JM. Changes in Gut Microbiome after Bariatric Surgery Versus Medical Weight Loss in a Pilot Randomized Trial. Obes Surg. 2019 Oct;29(10):3239-3245. doi: 10.1007/s11695-019-03976-4.

Reference Type: RESULT

PMID: 31256356 (View on PubMed)

Other Identifiers

R01DK089557

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK089557

Identifier Type: -

Identifier Source: org_study_id