Feasibility Study of a Low-Carb/Time-restricted Feeding Protocol in Insulin-Using Type 2 Diabetics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Effectiveness of Intervention: Changes in Hemoglobin A1c
研究概览
简要总结
The current paradigm of Type 2 Diabetes treatment relies heavily on expensive pharmacotherapy even though lifestyle factors are at the root of the condition. This study is designed to assess the feasibility of a low carbohydrate diet coupled with a time restricted feeding intervention to improve participant sensitivity, reducing their need for insulin. 20 participants will be invited to enroll from the 20 S Park St Clinic in Madison, WI and remain on study for up to 6 months.
详细描述
The investigators will perform a prospective cohort study of 20 insulin-using Type 2 diabetics who have primary care providers at 20 S Park St Clinic. Participants will be recruited from the Internal Medicine practices at the clinic. The subjects will meet with Dr. Zimmermann (Study Clinician) to review time restricted feeding and low-carbohydrate diets as well as a strategy for decreasing insulin doses. Calls from Dr. Zimmermann's clinic nurse will occur daily until blood glucose levels stabilize to manage insulin decrease.
Participants will complete monthly logs of food intake times and meet with a dietician twice during the 6-month study. Diabetes medication use will be reviewed, and hemoglobin A1c will be measured, at baseline and at 3 and 6 months. The participants' non-diabetic medical care will continue to be managed through their primary care physicians (PCPs).
Specific Aims:
-
Demonstrate feasibility of the low carbohydrate/time restricted feeding (LC/TRF) protocol
-
Feasibility will be assessed based on participant compliance with time-restricted feeding and recommended carbohydrate intake, clinician time and clinic resources
-
Determine effectiveness of the LC/TRF protocol on diabetes care and quality of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient of a primary care provider at 20 S Park Internal Medicine Clinic
- •Insulin using type 2 diabetic
- •Using glargine or detemir insulin for basal insulin dosing
- •Self-administering insulin
- •Hemoglobin A1c 7-10%.
- •Stable diabetes regimen for >3 months
- •Demonstrated reliability with glucose monitoring, A1c checks
- •BMI 25-35
排除标准
- •History consistent with type 1 diabetes
- •Using concentrated insulin (U200 or U300)
- •Living in a skilled nursing facility
- •Unwilling or unable to do frequent (3x daily) blood glucose checks
- •eGFR (estimated glomerular filtration rate) < 30 mL/min per 1.73 m2
- •Currently on steroids or warfarin
- •Hospitalized within 3 months
- •Symptomatic heart failure
- •Weight Loss >10% in last six months
- •History of organ transplantation
- •Pregnant/trying to become pregnant/breast feeding
结局指标
主要结局
Effectiveness of Intervention: Changes in Hemoglobin A1c
时间窗: baseline, 3 months, 6 months
Changes in A1c will be measured at baseline, 3 and 6 month MD visits. Data will be extracted from HealthLink by chart review. Comparisons will be made between post-intervention A1c scores and baseline scores, at 1 month and at 3 months using paired t-tests to detect whether patients experienced a positive outcome.
Effectiveness of Intervention: Changes in Insulin Dosage
时间窗: baseline, 3 months, 6 months
Changes in insulin dosage will be measured at baseline, 3 and 6 month MD visits. Data will be extracted from HealthLink by chart review.
次要结局
- Change in Appraisal of Diabetes Scale (ADS) Score(baseline, 3 months, 6 months)
- Effectiveness of Intervention: Changes in BMI(baseline, 3 months, 6 months)
- Participant Satisfaction(3 months, 6 months)
- Clinic-level feasibility: Average Hours of Support Time per Participant(up to 6 months)
- Feasibility: Percent of days where food was eaten within the target timeframe(up to 6 months)
- Feasibility: Average Daily Calories(up to 6 months)
- Feasibility: Percent of day compliant with Carbohydrate target(up to 6 months)