The eHealth Diabetes Remission Trial - Pilot Study (eDIT-pilot)
Ten study participants will consume a low-calorie total diet replacement for 12 weeks, have a 6-week food reintroduction phase (week 13-18) and continue with the weight loss maintenance phase until the end of the study (week 19-26). The weight loss goal is 15 kg (or 15% if body weight is bellow 80 kg). The primary study outcome iw weight loss after 6 months and the co-primary outcome is diabetes remission after 6 months (HbA1c < 48 mmol/mol). During the weight maintenance phase, if weight regain occurs or if HbA1c increases a rescue plan of total diet replacement will be recommended.
The participants will be supplied with the total diet replacement Modifast free of charge. Participants will be supplied with a scale, a finger-stick blood glucose meter and a blood pressure monitor. Participants will be advised to measure body weight, blood glucose and blood pressure every morning. The results are registered in the mobile phone application Telia Health Monitoring and are wirelessly transmitted to the project's physician, nurse and dietician. At the beginning of the food reintroduction phase the participants will receive an activity tracer and will be advised to increase their physical activity. Primary and secondary outcome measures will be estimated at the beginning and after 3 and 6 months. At the end of the study, all participants will take part in an individual semi-structured interview to investigate the participants' experience of diabetes remission and of the eHealth contact with the healthcare provider. After participants have completed the study, they will be followed at least once per year by obtaining data on blood sugar, HbA1c, body weight, blood pressure, medication usage and diabetes complications from the healthcare computer system.
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Umeå、スウェーデン、90187
- Department of Public Health and Clinical Medicine, Medicine
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Type 2 diabetes with diabetes duration 0 to 6 years
- BMI 27-45 kg/m2
- Owning a smartphone
- HbA1c 43-107 mmol/mol during the past 12 months (48-107 mmol/mol without blood sugar lowering medication)
Exclusion Criteria:
- Insulin treatment
- Weight loss 5 kg or more during the past 6 months
- Treatment with weight loss medication
- Diagnosed eating disorder
- eGFR < 30 ml/min/1.73m2
- Substance abuse
- Cancer
- Myocardial infarction during the past 6 months
- Severe heart failure
- Pregnancy
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Diabetes remission using total diet replacement and eHealth contact with the healthcare provider
This study has only one arm and no comparator.
|
Participants will replace usual foods with the commercially available total diet replacement Modifast (Impolin AB), which is delivered to them during the study period without any cost.
Participants will be supplied with a scale, a finger-stick blood glucose meter and a blood pressure monitor and will be advised to measure body weight, fasting blood glucose and blood pressure every morning.
The results are registered in the mobile phone application Telia Health Monitoring (Telia Sweden AB) and are wirelessly transmitted to the study team.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Weight loss
時間枠：6 months
|
Weight loss goal of 15 kg, measured at the research facilities
|
6 months
|
|
HbA1c
時間枠：6 months
|
The goal is diabetes remission with HbA1c < 48 mmol/mol without any diabetes medication.
(Secondary goal < 42 mmol/mol.)
|
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Semi-structured interviews
時間枠：6 months
|
6 months
|
|
|
Fasting blood glucose
時間枠：Daily measurements up to 6 months
|
Partial diabetes remission (< 7.0 mol/l), complete diabetes remission (<6.1 mol/l)
|
Daily measurements up to 6 months
|
|
Fasting blood glucose
時間枠：6 months
|
Partial diabetes remission (<7.0 mol/l), complete diabetes remission (<6.1 mol/l) without diabetes medication.
|
6 months
|
|
P-glucose 120 minutes after the oral glucose tolerance test
時間枠：6 months
|
Measured at the research facilities
|
6 months
|
|
Insulin secretion
時間枠：At baseline, 3 months and 6 months
|
Measured with oral glucose tolerance test
|
At baseline, 3 months and 6 months
|
|
Insulin sensitivity
時間枠：At baseline, 3 months and 6 months
|
Measured with oral glucose tolerance test
|
At baseline, 3 months and 6 months
|
|
Metabolic flexibility
時間枠：At baseline, 3 months and 6 months
|
Measured with indirect calorimetry during oral glucose tolerance test
|
At baseline, 3 months and 6 months
|
|
Blood pressure (systolic/diastolic)
時間枠：At baseline, 3 months and 6 months
|
Measured at the research facilities
|
At baseline, 3 months and 6 months
|
|
Blood pressure (systolic/diastolic)
時間枠：Daily measurements up to 6 months
|
Measured at home
|
Daily measurements up to 6 months
|
|
Blood pressure medication
時間枠：6 months
|
Change of blood pressure medication during the study
|
6 months
|
|
Body weight
時間枠：Daily measurements up to 6 months
|
Measured at home
|
Daily measurements up to 6 months
|
|
HbA1c
時間枠：Monthly measurement up to 6 months
|
Measured at home
|
Monthly measurement up to 6 months
|
|
Diabetes medication
時間枠：6 months
|
Change of diabetes medication during study duration
|
6 months
|
|
Plasma lipid profile
時間枠：At baseline, 3 months and 6 months
|
Measured at the research facilities
|
At baseline, 3 months and 6 months
|
|
Waist circumference
時間枠：Baseline, 3 months and 6 months
|
Measured in cm at the research facilities
|
Baseline, 3 months and 6 months
|
|
EQ-5D-5L
時間枠：At baseline, 3 months and 6 months
|
Questionnaire
|
At baseline, 3 months and 6 months
|
|
Food frequency form
時間枠：At baseline and 6 months
|
Questionnaire
|
At baseline and 6 months
|
|
Daily steps
時間枠：During the second three months of the study
|
Measured with activity tracker
|
During the second three months of the study
|
|
HbA1c follow up
時間枠：Yearly up to 20 years
|
Collected from patient journals after study completion
|
Yearly up to 20 years
|
|
Body weight follow up
時間枠：Yearly up to 20 years
|
Collected from patient journals after study completion
|
Yearly up to 20 years
|
|
Blood pressure follow up (systolic/diastolic)
時間枠：Yearly up to 20 years
|
Collected from patient journals after study completion
|
Yearly up to 20 years
|
|
Antidiabetic medication usage follow up
時間枠：Yearly up to 20 years
|
Collected from patient journals after study completion
|
Yearly up to 20 years
|
|
Blood pressure medication usage follow up
時間枠：Yearly up to 20 years
|
Collected from patient journals after study completion
|
Yearly up to 20 years
|
|
Diabetes complications follow up
時間枠：Yearly up to 20 years
|
Collected from patient journals and registries after study completion
|
Yearly up to 20 years
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。