N/A
Completed N=263
Jump Start Shared Medical Appointments for Diabetes With Weight Management
Source: ClinicalTrials.gov NCT01973972 ↗Enrolled (actual)
263
Serious AEs
20.5%
Results posted
Sep 2019
Primary outcomePrimary: Hemoglobin A1c — 8.2; 8.3 percentage of glycosylated hemoglobin
Summary
The proposed research will test a novel program that combines intensive weight management with shared (group) medical appointments for patients with diabetes. This research is important because diabetes is increasingly prevalent, it requires complex management by the provider and the patient, and weight loss is a critical component of its management. Adding weight management to shared medical appointments could potentially improve blood sugar control while reducing medications and their side effects such as low blood sugar.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1c |
8.2; 8.3 | — |
| SECONDARY Hypoglycemic Events |
3.2; 6.6 | — |
| SECONDARY Medication Effect Score |
2.2; 2.7 | — |
| SECONDARY Weight |
104.3; 108.0 | — |
| SECONDARY Estimated Costs of Intervention Strategies |
1513.42; 1264.49 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of type 2 diabetes,
- Hemoglobin A1c >= 8.0% or , >= 7.5 for those less than 50
- BMI >= 27 kg/m2,
- Interest in losing weight,
- Agrees to attend regular visits per study protocol,
- Has access to reliable transportation,
- Has a VAMC provider.
Exclusion Criteria
- Age >= 75 years old,
- Hemoglobinopathy that interferes with measurement of hemoglobin A1c,
- Certain chronic or unstable diseases that may put the participant at increased risk. These include the following:
- Kidney disease (serum creatinine >1.5 mg/dL in men, >1.3 mg/dL in women),
- Type 1 diabetes,
- Unstable CHD (unstable angina, current/active coronary ischemia workup),
- Blood pressure 160/100 mm Hg,
- Fasting triglycerides 600 mg/dL,
- Fasting serum LDL-C 190 mg/dL,
- Pregnancy, breastfeeding, or lack of birth control if premenopausal,
- 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),
- Enrollment in another research study that might affect the main outcomes of this study.
Data sourced from ClinicalTrials.gov (NCT01973972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.