Improving Glycemic Control Using a Virtual Weight Control Program Among Adults With Type 2 Diabetes
Megadott ok: Study sponsor cancelled funding prior to enrolment due to competing priorities.
Key facts
- Where
- Baton Rouge, Greensboro és Pittsburgh, Egyesült ÁllamokSee the 3 sites
Where in Egyesült Államok
- Pennington Biomedical Research CenterBaton Rouge, Egyesült ÁllamokNo longer taking part
- Wake Forest University Health SciencesGreensboro, Egyesült ÁllamokNo longer taking part
- University of Pittsburgh Health SciencesPittsburgh, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Pennington Biomedical Research Center
- Trial code
- NCT05663554
- Record updated
- 2026. április 28.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Weight loss of ≥ 5 kg in the previous 6 months; Taking prescription or over-the-counter weight loss medications within last 3 months; Thyroid disease for which the participant is untreated or has had treatment changed within the last 6 months. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 2 months is acceptable; Participation in another clinical trial within 30 days prior to enrollment; History of weight loss surgery; History of major surgery within three months of enrollment; Type 1 diabetes; Class II or higher congestive heart failure; Unstable heart disease (an ongoing workup or treatment for a cardiac symptom such as unstable angina, coronary ischemia); Presence of implanted cardiac defibrillator; Uncontrolled gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease; Current cancer or cancer treatment, or a history of cancer or cancer treatment within the last 3 years. Persons with successfully resected non-melanoma carcinoma of the skin may be enrolled; Dementia, psychiatric illness, or substance abuse that may interfere with adherence (e.g., illness that is currently unstable or resistant to first-line therapy; substance abuse in the past year); History of clinically diagnosed eating disorder including anorexia nervosa or bulimia nervosa; Any other condition or factor which in the opinion of the study physician or investigator makes it inadvisable for the candidate to participate in the trial; 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; More than 1 severe hypoglycemic event (requiring emergency medical services) in the past 12 months, unless the participant's physician provides written clearance for participation; Hemoglobinopathy that interferes with measurement of HbA1c; Participation in a weight control program within the past 3 months; Alanine Aminotransferase > 3 times the upper limit of normal (normal range is 7-56 IU/L); Blood pressure ≥160/100 mm Hg. If a potential participant has a blood pressure ≥160/100 mm Hg it is acceptable to re-test this potential participant within one week of the original test; Orthopedic limitations that would interfere with ability to engage in regular physical activity; Women who are pregnant, lactating, trying to become pregnant or unwilling to use an effective means of birth control; Currently consuming >14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and unwilling to limit intake to less than 3 drinks per day during study participation; Participation in WW anytime since November 2021.