| Eligibility |
Inclusion Criteria:
- 1. Participant reported diagnosis of Type 2 diabetes 2. HbA1c between 7%-11% (inclusive)
3. BMI 27-50 kg/m2 (inclusive) 4. Age range - 18 - 70 years (inclusive) 5. On stable
regimen of all medications (including diabetes) for at least 3 months (brief regimens of
medications such as antibiotics, steroids, etc. are permitted) 6. Willingness to attend
weekly WW Virtual Workshops and to participate in WW Digital program 7. Access to a iOS
smart phone device with internet 8. Willing to follow all requirements of study protocol
including blood draws at baseline, week 12, and week 24.
9. Willing and able to provide a valid email address for use in the study 10. Must be able
to communicate (oral and written) in English 11. Under the care of a physician who will be
responsible for managing the subject's diabetes and a subject who is willing to give
release to provide their treating MD with information about the trial
Exclusion Criteria:
- 1. Participation in a weight control program within the past 3 months 2. Weight loss
of = 5 kg in the previous 6 months 3. Taking prescription or OTC weight loss
medications within last 4 weeks 4. History of a surgical procedure for weight loss at
any time (e.g. gastroplasty, gastric by-pass, gastrectomy or partial gastrectomy,
adjustable banding, gastric sleeve) 5. History of major surgery within three months of
enrollment 6. Currently taking other medications that affect weight (e.g., paroxetine,
tricyclics, anti-psychotics) 7. Type 1 diabetes 8. Those on insulin or insulin
secretagogues 9. Renal insufficiency consisting of potassium over 5.5 (mmol/L) on a
non-hemolyzed specimen, or a creatinine over 2.5 mg/dL 10. Bilirubin over 3 (mg/dL) or
an albumin less than 3 (g/dL) 11. ALT > 3 (IU/L) times the upper limit of normal
(normal range is 7-56) 12. Evidence of more than 1 severe hypoglycemic event (episode
requiring emergency medical services) in the past 12 months, unless the participant's
treating physician provides written clearance for participation.
13. Hemoglobinopathy that interferes with measurement of hemoglobin A1c 14. Those on
higher doses of diuretics (furosemide 40mg or higher or comparable) 15. Unstable heart
disease (an ongoing workup or treatment for a cardiac symptom such as unstable angina,
coronary ischemia) 16. Presence of implanted cardiac defibrillator 17. Blood pressure
=180/100 mm Hg. If a potential participant has a BP above the inclusion criteria it is
acceptable to re-test this potential participant within one week of the original test.
18. 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 6 months is acceptable
19. Orthopedic limitations that would interfere with ability to engage in regular
physical activity 20. Uncontrolled gastrointestinal disorders including chronic
malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or
active gallbladder disease 21. 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.
22. 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), 23. History within the past five years of
clinically diagnosed eating disorders including anorexia nervosa or bulimia nervosa.
24. Women who are pregnant, lactating, trying to become pregnant or unwilling to use
an effective means of birth control 25. 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 drinking day during study participation 26.
Participation in another clinical trial within 30 days prior to enrollment. 27. 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
|
