Improving Diabetes Through Lifestyle and Surgery

Obesity Clinical Trial

— IDeaLS  

Official title:

Improving Diabetes Through Lifestyle and Surgery Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667783
• Other study ID #: DK089557
• Secondary ID: R01DK089557
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 2012
• Est. completion date: February 2015

Study information

• Verified date: April 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Obesity
• Type 2 Diabetes

Intervention

Procedure:
• Gastric Banding
Laparoscopic Adjustable Gastric Banding using the LapBand

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

Procedure:
• Gastric Bypass
Laparoscopic Roux-en-Y Gastric Bypass

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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- — View Citation

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/s11695-019-038 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c from baseline to final data collection	Participants will be followed until they reach 10% weight loss, anticipated average time 6 months, or up to 9 months.	Average time 6 months
Secondary	Change in insulin secretion	Participants will be followed until they reach 10% weight loss, and anticipated average of 6 months, or up to 9 months.	Average time 6 months