Health TrialsbyHealthPanel

The eHealth Diabetes Remission Trial

ConditionDiabetes Mellitus, Type 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorUmeå University

About this trial

Overweight patients with type 2 diabetes are offered a total diet replacement with the goal of weight loss and diabetes remission. Study participants are randomised to eHealth follow-up or face-to-face follow-up, but the dietary advice is the same in both groups. A healthy control group with normal glucose tolerance is examined once but is not randomised and does not receive any intervention.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Type 2 diabetes with duration 0-6 years

BMI 27 kg/m2 and higher

HbA1c 43 mmol/mol or higher (48 or higher if without diabetes medication)

Disqualifiers

Insulin treatment

Weight loss more than 5 kg during the past 6 months

Diagnosed eating disorder

eGFR < 30 ml/min/1,73m2

Trial design

Design model

Parallel

Treatments tested in this trial

  • Total diet replacement

    Behavioral

    Total diet replacement (850 kcal/day) for 3 months followed by weight maintenance for 21 months.

  • eHealth

    Behavioral

    All follow-up through an eHealth application and video meetings.

  • Face-to-face

    Behavioral

    All follow-up through face-to-face meetings.

Treatment groups

106 Participants
are divided into 3 treatment groups
Group A: eHealthExperimental treatment 2 interventions
Group B: Face-to-faceExperimental treatment 2 interventions
Group C: Healthy control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

HbA1c

HbA1c without diabetes medication as a continuous outcome (HbA1c correction according to Tsapas et al 2020 if on diabetes medication). The outcome will be tested for non-inferiority first, with a non-inferiority margin of 8 mmol/mol; followed by a test for superiority.

Time frame
12 months

Secondary outcomes

1

HbA1c

HbA1c without diabetes medication as a continuous outcome (HbA1c correction according to Tsapas et al 2020 if on diabetes medication). The outcome will be tested for non-inferiority first, with a non-inferiority margin of 8 mmol/mol; followed by a test for superiority.

Time frame
6 and 24 months
2

Diabetes remission

Number of participants with HbA1c \< 48 mmol/mol without diabetes medication. The outcome will be tested for non-inferiority first with a non-inferiority margin of 10 percentage points; followed by a test for superiority.

Time frame
6, 12 and 24 months
3

Body weight

Body weight as a continuous outcome

Time frame
6, 12 and 24 months
4

Achieved weight loss of at least 15 kg

Number of participants with achieved weight loss of at least 15 kg

Time frame
6, 12 and 24 months

Other outcomes

1

Insulin sensitivity

Hyperinsulinemic euglycemic clamp

Time frame
12 months
2

Insulin secretion

Stepped insulin secretion test with arginine

Time frame
12 months
3

Metabolic flexibility

Hyperinsulinemic euglycemic clamp

Time frame
12 months
4

Resting metabolic rate

Indirect calorimetry

Time frame
12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Umeå University

Lead sponsor

Region Västerbotten

Collaborator

Edgar Sjölunds Diabetes Foundation

Collaborator

Source ClinicalTrials.gov
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