Improving Glycemic Control Using a Virtual Weight Control Program Among Adults With Type 2 Diabetes (NCT05663554) | Clinical Trial Compass
WithdrawnNot Applicable
Improving Glycemic Control Using a Virtual Weight Control Program Among Adults With Type 2 Diabetes
Stopped: Study sponsor cancelled funding prior to enrolment due to competing priorities.
United States0Started 2023-01-15
Plain-language summary
The study is a randomized clinical trial with the primary aim of determining the effectiveness of the WW intervention at reducing HbA1c in patients with type 2 diabetes.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18.0 - 74.9 years of age
* Participant-reported diagnosis of type 2 diabetes
* HbA1c 7.0%-11% (inclusive)
* Overweight or obesity (BMI 25-50 kg/m2)
* On stable regimen of medications that can affect weight or diabetes outcomes for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted)
* Willingness to attend weekly WW Virtual Workshops and participate in WW Digital program
* Access to a smartphone/tablet that can download the WW app
* Willing and able to provide a valid email address for use in the study
* Be able to communicate (oral and written) in English
* Be under the care of a physician who will be responsible for managing the subject's diabetes and a participant who is willing to give release to provide their treating MD with information about the trial
* Be able to provide informed consent
Exclusion Criteria:
* Participation in a weight control program within the past 3 months
* Weight loss of ≥ 5 kg in the previous 6 months
* Taking prescription or over-the-counter weight loss medications within last 3 months
* History of weight loss surgery
* History of major surgery within three months of enrollment
* Type 1 diabetes
* Renal insufficiency consisting of potassium over 5.5 mmol/L on a non-hemolyzed specimen, or a creatinine \> 2.5 mg/dL
* Albumin \< 3 g/dL
* Alanine Aminotransferase \> 3 times the upper limit of normal (normal range is 7-56 IU/L)
* More than 1 severe hypoglycemic event (requiring e…