Moderate or Extensive Carbohydrate Reduction in Risk Patients (LOWinCHIP)
To Lower Glucose Levels and Reduce Weight by Exclusion of Carbohydrates and Inclusion of Psychological Behavioral Support
Risk-patients for diabetes or patients that are diagnosed with this condition but who are not treated with insulin are randomized two times, according to diet and according to the type of support:
Randomization with regard to carbohydrate restriction (25-30 E% or < 10E%). Randomization with regard to type of psychological support. Either according to Acceptance and Commitment Therapy or to traditional cognitive behavioral therapy. Both kinds of psychological support is given as group therapy.
Two-hundred patients are recruited and each patient is followed for two years.
調査の概要
詳細な説明
The organizers will recruit 200 patients in the study "To lower glucose levels and reduce weight by exclusion of carbohydrates and inclusion of psychological behavioral support" (LOWinCHIP) at the primary care health center "Cithyhälsan Centrum" in Norrköping. Each patient will be followed for 2 years. Patients are eligible if they have are above 18 years of age and have a BMI above 28 kg/m2 and also belong to one or more of the following groups: 1) type 2 diabetes that is not treated with insulin. 2) Patients that have had gestational diabetes or who have 3) first grade relative with type 2 diabetes. Finally 4) pre-diabetic individuals with impaired fasting glucose (6.1-6.9 mmol) or impaired glucose tolerance (capillary plasma glucose 8.9-12-1 after glucose challenge) are also potential participants. Patients must not have insulin therapy or severe kidney failure (GFR< 30). They can also not have severe physical restrictions for activity and they must not have difficulties with understanding written Swedish texts.
The participants are randomized two times (two by two factorial):
Randomization with regard to carbohydrate restriction (25-30 E% or < 10E%). Randomization with regard to type of psychological support. Either according to Acceptance and Commitment Therapy (ACT) or to traditional cognitive behavioral therapy. Each group will have three group sessions with approximately 8 participants followed by a telephone call by the therapist. Each session will be held by the psychologists that are part of the Cityhälsan Centrum staff.
The study has > 95% power to demonstrate 5% HbA1c (mmol/mol) difference between groups with a drop out of 25%.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Linkoping、スウェーデン、58185
- 募集
- University Hospital of Linkoping
-
コンタクト：
- Fredrik H Nystrom, MD, prof.
-
主任研究者：
- Fredrik H Nystrom, MD PhD prof
-
-
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:
- Diabetes without insulin. Patients at high risk for developing diabetes.
Exclusion Criteria:
- Severe kidney failure. Insulin therapy. Inability to understand instructions.
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：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
アクティブコンパレータ：Moderate carbohydrate restriction and traditional support
Moderate carbohydrate restriction and traditional support with group meetings
|
Randomization to moderate or extreme low-carbohydrate Mediterranean diet advice.
Randomization to group-based psychological support according to ACT or to traditional cognitive behavioral therapy
|
|
アクティブコンパレータ：Extreme low carbohydrate diet and traditional support
Extreme carbohydrate restriction and traditional support with group meetings
|
Randomization to moderate or extreme low-carbohydrate Mediterranean diet advice.
Randomization to group-based psychological support according to ACT or to traditional cognitive behavioral therapy
|
|
アクティブコンパレータ：Moderate carbohydrate restriction and ACT support
Moderate carbohydrate restriction and psychological support based on acceptance and commitment therapy
|
Randomization to moderate or extreme low-carbohydrate Mediterranean diet advice.
Randomization to group-based psychological support according to ACT or to traditional cognitive behavioral therapy
|
|
アクティブコンパレータ：Extreme carbohydrate restriction and ACT support
Extreme carbohydrate restriction and psychological support based on acceptance and commitment therapy
|
Randomization to moderate or extreme low-carbohydrate Mediterranean diet advice.
Randomization to group-based psychological support according to ACT or to traditional cognitive behavioral therapy
|
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 |
|---|---|---|
|
Long-term glucose levels
時間枠：2 years
|
HbA1c levels
|
2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quality of Life
時間枠：2 years
|
Quality of Life by questionnaires
|
2 years
|
|
Cardiovascular risk factors
時間枠：2 years
|
Lipids, body weight, glucose, ketones
|
2 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 (予想される)
研究の完了 (予想される)
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。
Diet regimeの臨床試験
-
Mondelēz International, Inc.KGK Science Inc.完了
-
Utah State UniversityGreenAcres Foundation積極的、募集していない
-
piero portincasaKing's College London; Uppsala University; University of Coimbra; Technical University of Munich; Martin-Luther-Universität... と他の協力者まだ募集していません
-
International Centre for Diarrhoeal Disease Research...募集